Latest news with #growthhormone
Yahoo
12-05-2025
- Health
- Yahoo
Novo Nordisk A/S: Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE
The REAL8 trial showed that after 52 weeks, once-weekly Sogroya® (somapacitan) had similar clinical outcomes and safety profile to once-daily Norditropin® (somatropin) in children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature3. Superiority was achieved for once-weekly somapacitan versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. These conditions are often associated with significant health challenges and a high treatment burden from daily injections4, which can lead to a lack of adherence and put successful treatment outcomes at risk. Novo Nordisk is committed to bringing our expertise and scientific innovation to help improve the lives of children with conditions that impact their growth. Bagsværd, Denmark, 12 May 2025 – Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature (ISS)3. In addition, superiority was achieved for once-weekly Sogroya® versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. REAL8 data showed that Sogroya® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone1-3. Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya® was similar to those treated with daily growth hormone1-3. Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark1-3. 'Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,' said Professor Agnès Linglart, Professor of Paediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8. 'The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.' The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: In children born SGA, Sogroya® demonstrated superior estimated mean HV when compared with a lower dose (0.035 mg/kg/day) of somatropin (11.0 vs 9.4 cm/year), and non-inferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of somatropin (11.0 vs 11.1 cm/year)1. In children with NS, Sogroya® demonstrated superior estimated mean HV compared with somatropin (10.4 vs 9.2 cm/year)2. In children with ISS, Sogroya® demonstrated non-inferior estimated mean HV compared with daily somatropin (10.5 vs 10.5 cm/year)3. Non-adherence to growth hormone treatment is a common problem which puts successful treatment outcomes at risk. Daily injections can be a burden for children and their caregivers, leading to lack of adherence due to discomfort or pain at injection sites, inconvenience and disruption to daily life5. One study showed that missed daily injections resulted in a difference of 6.1 cm in height over 3 years when comparing nonadherent with adherent patients4. 'Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health,' said Martin Lange, executive vice president for Development at Novo Nordisk. 'We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment.' In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US. About REAL8The REAL8 study is part of the ongoing REAL clinical trial programme, it is a randomised, open-label, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of once-weekly Sogroya® (somapacitan) in children born SGA, or with TS, NS or ISS. The primary treatment period was 52 weeks followed by a two-year safety extension phase6. REAL8 has an innovative basket trial design that is investigating once-weekly Sogroya® (somapacitan) in four different but related indications (SGA, TS, NS and ISS) under one trial protocol6. This trial design allows for a more efficient clinical development process by speeding up recruitment and consolidating resources7, potentially bringing treatment to patients with these conditions sooner. This is the first time a trial design of this type has been implemented in the growth disorder space. In REAL8, pre-pubertal children with NS, TS or ISS were randomised to receive either once-weekly Sogroya® (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day; children born SGA were randomised to receive either somapacitan 0.24 mg/kg/week, or low dose of somatropin 0.035 mg/kg/day, or high dose of somatropin 0.067 mg/kg/day6. About REAL9The REAL9 study is part of the ongoing REAL clinical trial programme, it is a single-group assignment, phase 3 study evaluating the safety and efficacy of once-weekly Sogroya® (somapacitan) in children 10 years or older born SGA, or with TS, NS or ISS. The study will last for approximately 3 years8. About once-weekly Sogroya® Once-weekly Sogroya® (somapacitan) is a prescription human growth hormone analogue, similar to current daily growth hormone. It is currently approved for once-weekly treatment of children and adults who do not produce enough growth hormone9,10. Using albumin-binding prolongation technology, Sogroya® attaches to albumin, a protein in the blood, to help delay its removal from the body. This well-established technology has been used for over 20 years in Novo Nordisk's diabetes treatment. It allows for the growth hormone to work longer11. About Novo NordiskNovo 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@ David Heiberg Landsted +45 3077 6915 dhel@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649 idmg@ Frederik Taylor Pitter +1 609 613 0568fptr@ References1. Linglart A, Bottcher V, Rassmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4131.2. Jorge A, Albanese A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Noonan Syndrome: Randomised Phase 3 Trial. Poster presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4118.3. Abuzzahab J, Dauber A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4048.4. Loftus J, Miller BS, Parzynski CS, et al. Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency. Endocr Pract. 2022;28:565-571.5. Brod M, Hojbjerre L, Alolga SL, et al. Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient. 2017;10:653-666.6. NCT05330325. A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (REAL 8). Available at: Last accessed: May 2025.7. Definitive Healthcare. Basket trial. Available at: Last accessed: April 2025.8. NCT05723835. A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (REAL 9). Available at: Last accessed: May 2025.9. Sogroya® (somapacitan): SmPC. 2025 [online] Available at: Last accessed: May 2025.10. Sogroya® (somapacitan-beco injection) US PI. 2025 [online] Available at: Last accessed: May 2025.11. Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59:1410-1419. Attachment PR250512-ESPE-ESE-2025-REAL8
Yahoo
12-05-2025
- Health
- Yahoo
Novo Nordisk A/S: Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE
The REAL8 trial showed that after 52 weeks, once-weekly Sogroya® (somapacitan) had similar clinical outcomes and safety profile to once-daily Norditropin® (somatropin) in children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature3. Superiority was achieved for once-weekly somapacitan versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. These conditions are often associated with significant health challenges and a high treatment burden from daily injections4, which can lead to a lack of adherence and put successful treatment outcomes at risk. Novo Nordisk is committed to bringing our expertise and scientific innovation to help improve the lives of children with conditions that impact their growth. Bagsværd, Denmark, 12 May 2025 – Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature (ISS)3. In addition, superiority was achieved for once-weekly Sogroya® versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. REAL8 data showed that Sogroya® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone1-3. Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya® was similar to those treated with daily growth hormone1-3. Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark1-3. 'Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,' said Professor Agnès Linglart, Professor of Paediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8. 'The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.' The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: In children born SGA, Sogroya® demonstrated superior estimated mean HV when compared with a lower dose (0.035 mg/kg/day) of somatropin (11.0 vs 9.4 cm/year), and non-inferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of somatropin (11.0 vs 11.1 cm/year)1. In children with NS, Sogroya® demonstrated superior estimated mean HV compared with somatropin (10.4 vs 9.2 cm/year)2. In children with ISS, Sogroya® demonstrated non-inferior estimated mean HV compared with daily somatropin (10.5 vs 10.5 cm/year)3. Non-adherence to growth hormone treatment is a common problem which puts successful treatment outcomes at risk. Daily injections can be a burden for children and their caregivers, leading to lack of adherence due to discomfort or pain at injection sites, inconvenience and disruption to daily life5. One study showed that missed daily injections resulted in a difference of 6.1 cm in height over 3 years when comparing nonadherent with adherent patients4. 'Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health,' said Martin Lange, executive vice president for Development at Novo Nordisk. 'We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment.' In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US. About REAL8The REAL8 study is part of the ongoing REAL clinical trial programme, it is a randomised, open-label, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of once-weekly Sogroya® (somapacitan) in children born SGA, or with TS, NS or ISS. The primary treatment period was 52 weeks followed by a two-year safety extension phase6. REAL8 has an innovative basket trial design that is investigating once-weekly Sogroya® (somapacitan) in four different but related indications (SGA, TS, NS and ISS) under one trial protocol6. This trial design allows for a more efficient clinical development process by speeding up recruitment and consolidating resources7, potentially bringing treatment to patients with these conditions sooner. This is the first time a trial design of this type has been implemented in the growth disorder space. In REAL8, pre-pubertal children with NS, TS or ISS were randomised to receive either once-weekly Sogroya® (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day; children born SGA were randomised to receive either somapacitan 0.24 mg/kg/week, or low dose of somatropin 0.035 mg/kg/day, or high dose of somatropin 0.067 mg/kg/day6. About REAL9The REAL9 study is part of the ongoing REAL clinical trial programme, it is a single-group assignment, phase 3 study evaluating the safety and efficacy of once-weekly Sogroya® (somapacitan) in children 10 years or older born SGA, or with TS, NS or ISS. The study will last for approximately 3 years8. About once-weekly Sogroya® Once-weekly Sogroya® (somapacitan) is a prescription human growth hormone analogue, similar to current daily growth hormone. It is currently approved for once-weekly treatment of children and adults who do not produce enough growth hormone9,10. Using albumin-binding prolongation technology, Sogroya® attaches to albumin, a protein in the blood, to help delay its removal from the body. This well-established technology has been used for over 20 years in Novo Nordisk's diabetes treatment. It allows for the growth hormone to work longer11. About Novo NordiskNovo 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@ David Heiberg Landsted +45 3077 6915 dhel@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649 idmg@ Frederik Taylor Pitter +1 609 613 0568fptr@ References1. Linglart A, Bottcher V, Rassmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4131.2. Jorge A, Albanese A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Noonan Syndrome: Randomised Phase 3 Trial. Poster presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4118.3. Abuzzahab J, Dauber A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4048.4. Loftus J, Miller BS, Parzynski CS, et al. Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency. Endocr Pract. 2022;28:565-571.5. Brod M, Hojbjerre L, Alolga SL, et al. Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient. 2017;10:653-666.6. NCT05330325. A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (REAL 8). Available at: Last accessed: May 2025.7. Definitive Healthcare. Basket trial. Available at: Last accessed: April 2025.8. NCT05723835. A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (REAL 9). Available at: Last accessed: May 2025.9. Sogroya® (somapacitan): SmPC. 2025 [online] Available at: Last accessed: May 2025.10. Sogroya® (somapacitan-beco injection) US PI. 2025 [online] Available at: Last accessed: May 2025.11. Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59:1410-1419. Attachment PR250512-ESPE-ESE-2025-REAL8Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Zawya
12-05-2025
- Health
- Zawya
Sandoz launches new OMNITROPE growth hormone concentration in Egypt
Egypt - Sandoz, a global leader in generic and biosimilar medicines, announced on Sunday the introduction of its 15mg/1.5ml concentration of the OMNITROPE biosimilar growth hormone to the Egyptian market for the treatment of short stature. This initiative aligns with Sandoz's ongoing efforts to support Egypt's Vision 2030 and local healthcare authorities' commitment to enhancing public health. The company stated that the newly available concentration aims to help expand access to growth hormone, noting that an estimated 17% of Egyptian children suffer from short stature. Research conducted at Suez Canal University's endocrinology outpatient clinic, released in 2024, indicated that growth hormone treatment significantly improves physical, social, psychological, and environmental quality of life. Dr. Mona Salem, Professor of Paediatric Endocrinology at Ain Shams University and President of the Egyptian Society of Paediatric Endocrinology & Diabetes, said: 'In children and adolescents, growth hormone is used to treat growth disturbance due to insufficient secretion of growth hormone, associated with Turner syndrome, with chronic renal insufficiency, in short children/adolescents born small for gestational age, or associated with Prader-Willi syndrome (PWS). The biosynthetic/synthetic hormone is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH).' Dr. Salem added, 'Short stature is diagnosed in children or adolescents who are well below the average height for their age and gender, which may be due to genetic factors or underlying health conditions. Studies show that short stature prevalence varies geographically, with a genetic predisposition, as well as nutritional and environmental factors, playing an important role.' A cross-sectional study conducted between January 2018 and January 2020 involving 33,150 Egyptian children aged 6 to 11 showed that 17% of the sample had short stature, with 40.8% attributed to familial factors and 24.2% to constitutional causes. Dr. Rasha Tarif, Head of the Paediatric Endocrinology Unit at Ain Shams University and Chair of the European Society for Paediatric Endocrinology (ESPE) Education and Training Committee, stated: 'As noted, short stature affects children and adolescents, not only physically but also psychologically. Growth hormone is one of the most effective treatments for the aforementioned growth disturbances. The dosage is carefully calculated based on weight, underlying cause, puberty stage, as well as stimulated growth hormone test results, to achieve the best possible final height outcomes.' Dr. Tarif emphasised that young patients require therapeutic intervention before growth plates fuse, after which height cannot be gained. She added, 'Growth hormone plays a critical role in effective treatment plans, but ensuring its availability has been a challenge in recent years. This challenge is being addressed through ongoing efforts to secure sufficient quantities to ensure uninterrupted treatment until puberty is complete, and in some cases, for life. Treatment continuity, along with proper follow-up with a specialized physician, is essential for achieving optimal results.' Sandoz said the new concentration is being made available at an affordable cost, expanding treatment options and aiming for better patient response and an effective, safe treatment journey by minimising interruptions. The company stated that securing the reliable availability of this human growth hormone reinforces medical efforts to provide comprehensive care. Sameh Elbagoury, Sandoz Egypt Country Head, said: 'The Egyptian government, within the context of the Egypt Vision 2030, has shown strong commitment to reducing the prevalence of short stature among children, aiming to improve public health for current and future generations, and help build a healthier, more productive workforce, in line with the national vision for sustainable development.' Elbagoury added: 'Our top priority at Sandoz is to develop affordable biosimilars for high-quality biologics and ensure that as many patients as possible have access to them. Introducing the 15mg concentration of our well-established Omnitrope growth hormone allows us to help local authorities meet the increase in demand for growth hormones, reflecting the positive impact and notable success achieved by the Presidential Initiative for the Early Detection of Anaemia, Obesity and Short Stature.' Sandoz Omnitrope received approval from the US Food and Drug Administration and the European Medicines Agency in 2006, with subsequent approvals in other countries. Sandoz has also established a long-term, post-marketing surveillance programme for the product.
Zawya
11-05-2025
- Health
- Zawya
Sandoz Egypt introduces OMNITROPE 15mg biosimilar growth hormone for the treatment of short stature
17% of Egyptian children suffer from short stature; newly available 15mg/1.5ml concentration to help expand access to growth hormone Growth hormone treatment meaningfully improves physical, social, psychological and environmental quality of life according to research¹ Cairo – Sandoz the global leader in generic and biosimilar medicines, today announced the introduction of its 15mg/1.5ml concentration of the OMNITROPE biosimilar growth hormone for the treatment of short stature to the Egyptian market, as part of its ongoing efforts to support Egypt's Vision 2030. Local healthcare authorities remain committed to addressing various health challenges to enhance public health for current and future generations, and help build a healthier, more productive workforce. Research conducted at the Suez Canal University endocrinology outpatient clinic in Ismailia City, Egypt and released in 2024, underscored the importance of short stature treatment, with findings indicating that treatment with growth hormone significantly improved physical, social, psychological, and environmental quality of life¹. 'In children and adolescents, growth hormone is used to treat growth disturbance due to insufficient secretion of growth hormone, associated with Turner syndrome, with chronic renal insufficiency, in short children/adolescents born small for gestational age, or associated with Prader-Willi syndrome (PWS). The biosynthetic/synthetic hormone is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH)² ³,' Dr. Mona Salem, Professor of Paediatric Endocrinology at Ain Shams University and President of the Egyptian Society of Paediatric Endocrinology & Diabetes, said. 'Short stature is diagnosed in children or adolescents who are well below the average height for their age and gender, which may be due to genetic factors or underlying health conditions⁴ ⁵. Studies show that short stature prevalence varies geographically, with a genetic predisposition, as well as nutritional and environmental factors, playing an important role⁶,' Dr Salem added. A cross-sectional study conducted between January 2018 and January 2020 involving 33,150 Egyptian children aged 6 to 11 showed that 17% of the sample had short stature, with 40.8% attributed to familial factors and 24.2% to constitutional causes⁷. "As noted, short stature affects children and adolescents, not only physically but also psychologically. Growth hormone is one of the most effective treatments for the aforementioned growth disturbances. The dosage is carefully calculated based on weight, underlying cause, puberty stage, as well as stimulated growth hormone test results, to achieve the best possible final height outcomes," Dr. Rasha Tarif, Head of the Paediatric Endocrinology Unit at Ain Shams University and Chair of European Society for Paediatric Endocrinology (ESPE) Education and Training Committee, said. Young patients affected require therapeutic intervention to accelerate growth velocity before growth plates have fused, after which the height cannot be gained. Human growth hormone must therefore be administered during this window of opportunity to ensure a normal final adult height⁸. 'Growth hormone plays a critical role in effective treatment plans, but ensuring its availability has been a challenge in recent years. This challenge is being addressed through ongoing efforts to secure sufficient quantities to ensure uninterrupted treatment until puberty is complete, and in some cases, for life. Treatment continuity, along with proper follow-up with a specialized physician, is essential for achieving optimal results,' Dr. Tarif added. This new concentration is being made available and at an affordable cost, expanding treatment options in line with the latest global scientific standards. This will allow for a better patient response as well as an effective and safe treatment journey by minimizing interruptions. Securing the reliable availability of this human growth hormone reinforces medical efforts to provide comprehensive care for children and reflects the Egyptian medical community's commitment to delivering advanced treatment solutions for patients in need. "The Egyptian government, within the context of the Egypt Vision 2030, has shown strong commitment to reducing the prevalence of short stature among children, aiming to improve public health for current and future generations, and help build a healthier, more productive workforce, in line with the national vision for sustainable development," Sameh Elbagoury, Sandoz Egypt Country Head, said. 'Our top priority at Sandoz is to develop affordable biosimilars for high-quality biologics and ensure that as many patients as possible have access to them. Introducing the 15mg concentration of our well-established Omnitrope growth hormone allows us to help local authorities meet the increase in demand for growth hormones, reflecting the positive impact and notable success achieved by the Presidential Initiative for the Early Detection of Anaemia, Obesity and Short Stature,' Elbagoury added. Sandoz Omnitrope was approved by the US Food and Drug Administration and the European Medicines Agency in 2006 and approvals in other countries have since followed. Sandoz has also established a long-term, post-marketing surveillance program for its product to monitor its safety over time⁹. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world's first oral penicillin in 1951, and the world's first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.
