Latest news with #SOUL
Scottish Sun
29-07-2025
- Entertainment
- Scottish Sun
Family pay touching tribute to ‘shining star' daughter, 19, who died in crash with lorry on way to theatre performance
Rosa lived and breathed performing arts and starred in theatre 'LOVING SOUL' Family pay touching tribute to 'shining star' daughter, 19, who died in crash with lorry on way to theatre performance A HEARTBROKEN family have paid a moving tribute to their 19-year-daughter after she died in a horror crash. Aspiring actress Rosa Taylor was on her way to a theatre show in Corsham, Wiltshire, when the car she was in collided with a lorry. Advertisement The fatal smash involved a Hyundai i10 and a Scania Tipper HGV and happened at around 1.30pm on July 24 on the A4 Bath Road near Wiltshire's border with Somerset. Rosa was sadly pronounced dead at the scene. Rosa's father Gareth Taylor paid tribute to his daughter today, saying: "Anyone who knew Rosa would agree that she was the most beautiful person inside and out. "She was the very definition of a spirit that shines brightly and dies young, loved by anyone who met her. Advertisement Read More in UK News TOMMY SPEAKS OUT Tommy Robinson posts video on X as he FLEES UK after station 'assault' "She was at once the most talented, most beautiful, and most loving soul I've ever known." Rosa was also remembered by those close to her as 'a shining star,' 'the greatest friend anyone could have asked for,' and the 'most naturally gifted performer you had ever seen.' A theatre kid from birth, Rosa lived and breathed performing arts. She played lead roles at the Artz Centre in Skelmersdale before heading to the Liverpool Institute for Performing Arts (LIPA) Sixth Form College to study Musical Theatre. Advertisement Before her passing, she had just secured her place at Trinity Laban Conservatoire in London and was due to start in September. A natural born performer who lived for the stage, Rosa performed with Liverpool Empire Youth Theatre in productions such as Legally Blonde: The Musical. Just recently she performed in Wow Liverpool's WOW That's What I Call Musicals at the Liverpool Playhouse. In July 2025, Rosa hit the road as the lead in the Beggars Belief Collective production of SCRUMPTIOUS!. Advertisement Rosa also worked as an entertainer at children's birthday parties. She performed as beloved characters and celebrities such as Ariana Grande, Aladdin's Jasmine, and Beauty and The Beast's Belle to put a smile on young kids' faces. Rosa also worked at Briar's Hall Hotel in Ormskirk. After the crash, a spokesperson for Wiltshire Police said: "Our thoughts are with her family and friends at this time. Advertisement "Any witnesses or anyone with dash cam footage should contact the Serious Collision Investigation Team on 01225 694597 quoting log 54250100571. "Alternatively you can contact the team directly by emailing SCIT@
Yahoo
23-06-2025
- Health
- Yahoo
Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
Yahoo
23-06-2025
- Health
- Yahoo
Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
Yahoo
23-06-2025
- Health
- Yahoo
Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
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10-06-2025
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Novo Nordisk to present array of new portfolio data including studies with semaglutide and CagriSema, expanding evidence in obesity and diabetes care at ADA 2025
Full data of Phase 3 REDEFINE 1 and 2 trial results will provide insights on the potential of CagriSema Semaglutide real-world data complements evidence from previous cardiometabolic and kidney outcomes trials Data on pipeline candidate amycretin to underscore Novo Nordisk's scientific efforts to continued innovation in obesity PLAINSBORO, N.J., June 10, 2025 /PRNewswire/ -- Novo Nordisk today announced that new data from its industry-leading cardiometabolic portfolio will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago, June 20 – 23, 2025. A total of 29 abstracts will be presented, including trials investigating the efficacy and safety of CagriSema in people with overweight/obesity (REDEFINE 1) and those with overweight/obesity and type 2 diabetes (REDEFINE 2).1 Further, new data will complement the extensive body of cardiometabolic and kidney evidence for semaglutide in people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from additional real-world studies in adults with obesity.2-4 "We recognize the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalized treatment approach," said Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. "As we look to build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease." The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk's scientific efforts to deliver innovation in cardiometabolic diseases and individualized healthcare solutions.1 On June 22nd, Novo Nordisk will also host an R&D investor event on our metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. Full details of Novo Nordisk abstracts to be presented at ADA 2025. These data for medicines containing semaglutide, CagriSema, amycretin, insulin icodec, and IcoSema are investigational: ADA Scientific Sessions:
