Latest news with #IgANephropathy
Medscape
2 days ago
- Health
- Medscape
Sibeprenlimab Halves uPCR in IgA Nephropathy Trial
VIENNA — Sibeprenlimab, a novel selective immune antibody, reduced the urine protein-to-creatinine ratio (uPCR) by more than half in patients with immunoglobulin A (IgA) nephropathy, according to an interim analysis of the VISIONARY trial. Beyond this clinical effect, a notable observation was the lack of safety concerns, especially given that, although sibeprenlimab is a selective agent, there may have been unexpected off-target effects. 'Safety's been a key consideration with these drugs,' study presenter Vlado Perkovic, MD, PhD, provost and scientia professor, University of New South Wales, Sydney, Australia, told Medscape Medical News . Sibeprenlimab represents a new mechanism of action and 'we don't yet fully understand the profile, so we've been looking at that data very carefully,' explained Perkovic. 'In particular, the infection risk has been my biggest concern, given we know that infections are dramatically increased in people with steroid therapy for example, in IgA nephropathy.' The results of the trial — the largest to date in the field — were presented at the 62nd European Renal Association Congress 2025 on June 6 and drew a warm applause from the audience. An Underestimated Condition IgA nephropathy is estimated to affect 2.5 per 100,000 people per year, although 'it's possible that that number is a significant underestimate,' said Perkovic. Diagnosis typically occurs between 20 and 40 years of age. And, despite supportive care, the majority of patients have a high lifetime risk of end-stage kidney disease (ESKD), with up to 50% of patients progressing to ESKD within 20 years of their clinical presentation. 'It's quite likely we've underestimated just how important this condition is,' said Perkovic, but 'we're fortunate that we're in the middle of something of a golden age of developing new treatments.' A number of therapies have been shown to reduce the risks associated with the disease, although they do not necessarily address the immunological basis of the condition. In addition to newer treatments, 'corticosteroids have long been used for people with IgA nephropathy,' Perkovic said, 'but of course, corticosteroids also have a range of different effects across the immune system,' which can lead to adverse outcomes. Sibeprenlimab is a selective IgG2 antibody that binds to and inhibits the biological activity of APRIL (a proliferation-inducing ligand), which is produced by mucosal epithelial and myeloid cells and binds to B cells. APRIL regulates B-cell-mediated immune responses and mediates IgG and IgA class switching in mature B cells. It is these two actions that make APRIL a key factor in the so-called 4-Hit process in the pathogenesis of IgA nephropathy, which results in the deposition of immune complexes in the glomerulus, leading to proteinuria and loss of kidney function. Phase 3 VISIONARY TRIAL Following on from the successful phase 2 ENVISION trial of sibeprenlimab, the researchers undertook the phase 3 VISIONARY trial, an ongoing study involving patients with biopsy-confirmed IgA nephropathy from 240 sites in 31 countries, who were randomized to sibeprenlimab or placebo for 100 weeks and followed up for a further 12 weeks. All patients were required to have a uPCR of ≥ 0.75 g/g or urine protein excretion of ≥ 1.0 g/day, an estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m2, and to have been on a stable dose of either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, with or without a SGLT2 inhibitor, for ≥ 3 months prior to screening. For the current pre-specified interim analysis, Perkovic reported the efficacy and safety results in the first 320 randomized patients (152 in the sibeprenlimab group and 168 in the placebo group), focusing on the primary endpoint of 24-hour uPCR at 9 months vs baseline, with eGFR and other data expected to be presented in 2026. The median age of the patients was 42-43 years. There were proportionally fewer females in the sibeprenlimab group (34.2%) vs the placebo group (40.5%). The majority of the patients were Asian, at 61.8% and 56.5%, respectively. Compared with a rise in uPCR at the 9-month follow-up in the placebo group, sibeprenlimab was associated with a 50.2% reduction in uPCR, giving a highly significant placebo-adjusted treatment effect of 51.2% ( P < .0001). Importantly, the benefit of sibeprenlimab on uPCR was seen as early as 4 weeks after initiating treatment and continued to accrue throughout follow-up. Ronald T. Gansevoort, MD, PhD, professor of medicine and a nephrologist at the Department of Nephrology, University Medical Center Groningen, Netherlands, who co-chaired the session, told Medscape Medical News that the results look 'very promising.' 'Recently, we have had several agents working in different ways that all show proteinuria lowering,' he continued, but the results from those studies show that the improvements seen in VISIONARY are 'the best proteinuria lowering' seen so far. Gansevoort noted, however, that this remains an interim analysis, and that he is really looking forward to seeing the kidney function results, adding: 'It was a little bit of a pity that they were not allowed to show at least the 9-month interim data on kidney function, which would have been so interesting.' Safety Results In terms of safety, the proportion of patients experiencing a treatment-related treatment-emergent adverse event (TEAE) was marginally lower with sibeprenlimab, at 32.9% vs 31.0% with placebo. The proportion of patients having a TEAE that led to treatment discontinuation was 0.7% vs 2.4%, respectively, and there were fewer severe and serious TEAEs with the experimental drug. 'If we focus on the infection-related adverse events,' Perkovic said, 'we can see that rates were numerically slightly higher in the sibeprenlimab than the placebo group, with a pattern that was broadly consistent, but with perhaps a slight excess of COVID 19.' He noted that this was 'the reverse of the pattern we've seen in the phase 2 trials, suggesting a chance' outcome. 'The data so far look remarkably encouraging,' he added. There's really no suggestion of an increased risk of infection,' with no opportunistic infections identified, 'and certainly no deaths.' More data is required from the ongoing follow-up to support what has been observed so far, but if the final results do bear out both the efficacy and safety outcome, it will show that sibeprenlimab is 'a precision approach to the fundamental abnormality in IgA nephropathy: that's the really exciting part,' said Perkovic. The study was funded by Otsuka Pharmaceutical Development and Commercialization. Perkovic declares relationships with Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Chinook Therapeutics, Eli Lilly & Company, Gilead Sciences, GlaxoSmithKline, Guard Therapeutics, Incyte, Janssen, Merck, Mitsubishi Tanabe Pharma, Mundipharma, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi, Shaanxi Micot Technology, Travere Therapeutics.
Yahoo
26-05-2025
- Business
- Yahoo
CSL (ASX:CSL) Secures NICE Approval For Sparsentan Use In NHS England
CSL saw its stock price rise by 3% over the last month, amid important developments and a fluctuating market environment. CSL Vifor's notable progress with the National Institute for Health and Care Excellence recommending sparsentan for primary IgA nephropathy treatment may have provided positive momentum. This significant medical endorsement, alongside CSL's continued engagement with shareholders through meetings, could have added weight to its share performance. Meanwhile, broader market volatility, influenced by global trade tensions and declining major indexes, may have tempered the extent of CSL's gains, which align closely with general market movement, as the market faced a 1% decline. We've spotted 1 possible red flag for CSL you should be aware of. The latest GPUs need a type of rare earth metal called Dysprosium and there are only 24 companies in the world exploring or producing it. Find the list for free. The recent developments regarding CSL's approval for sparsentan, a treatment recommended by the National Institute for Health and Care Excellence, may enhance the company's market position, potentially fueling revenue growth. Over the past three years, however, CSL's total return, inclusive of share price changes and dividends, recorded a decline of 4.64%. This contrasts against a broader 1-year underperformance both relative to the Australian market's 4.9% increase and the Australian Biotechs industry's -9.4% decrease, highlighting a need to bridge the performance gap with new advancements. Looking forward, the impact of these medical endorsements might influence CSL's revenue and earnings forecasts positively, with anticipated expansion in the HAE and vaccine sectors playing a crucial role. Despite the current share price of A$251.13 being lower than the consensus analyst price target of A$311.94, suggesting a potential upswing, the market's fluctuations must be considered in investment evaluations. As CSL continues to hone operational efficiencies and product rollouts, assessing these factors against earnings projections will be vital in understanding its long-term trajectory. According our valuation report, there's an indication that CSL's share price might be on the cheaper side. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ASX:CSL. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Yahoo
23-05-2025
- Health
- Yahoo
England's NICE recommends FILSPARI® (sparsentan) as a treatment option for IgA nephropathy
First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3 NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4 ST. GALLEN, Switzerland, May 23, 2025 /CNW/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5 What this means in practice is that there is enough evidence to show that sparsentan provides benefits and value for money, so it can be used routinely if it is considered the most suitable treatment option in this population.3 Sparsentan must be funded in England within 90 days of final publication of this guidance3 which is expected to be 27 June 2025. Professor Jonathan Barratt, Professor of Renal Medicine at University Leicester, UK, welcomed the NICE decision as a major advancement in the treatment of IgA nephropathy in the UK. "IgA nephropathy is a condition with an average age at diagnosis of around 40 years.6 Due to disease progression, a patient's kidneys may fail. Treatments, such as sparsentan, that have been developed for IgA nephropathy are urgently needed, our goal being to improve outcomes for these patients." IgA nephropathy is characterised by the buildup of a faulty version of immunoglobulin A (IgA), which accumulates in clusters in small blood vessels in the kidney, called glomeruli, that filter the blood. These clumps damage the glomeruli causing leakage of blood (haematuria) and protein (proteinuria) into the urine resulting in a progressive loss of kidney function. Proteinuria is a major risk factor for IgA nephropathy progression, increasing the risk of kidney failure.6-8 Despite current treatments, some patients with IgA nephropathy do not achieve adequate proteinuria reduction and remain at risk of progression.9 Although classified as rare, IgA nephropathy is the most common type of primary glomerular disease worldwide, with over 22,000 adults estimated to have the condition in England.10 Patients generally face a poor prognosis if the condition is not appropriately controlled, with approximately 30-40% of patients developing kidney failure within 10 years of diagnosis.11 Current medical treatment guidelines by KDIGO (Kidney Disease, Improving Global Outcomes) state that patients who are at high risk of progressive chronic kidney disease, despite maximal supportive care, are those with persistent urine protein excretion >1 g/day.12 Underscoring the importance of the NICE recommendation for IgA nephropathy patients and their communities, Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor said: "We are very pleased that NICE recognised the value of our innovative therapy which helps to address a clear unmet medical need in patients with IgA nephropathy. We look forward to working with the National Health Service to ensure access to this important medicine as soon as possible as we continue to deliver on our promise to patients." CSL Vifor expects to launch sparsentan in the UK in the second half of 2025; commercial stock will be available from July 2025. Notes to Editors On 15th April 2025, the MHRA granted the marketing authorisation for sparsentan based on the final results of the Phase 3 PROTECT double blind study.5 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialise in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, About IgA nephropathy Primary immunoglobulin A nephropathy (IgA nephropathy) is a rare, progressive type of chronic kidney disease (CKD) that is often diagnosed in adults before the age of 40 years.6 CKD is characterised by abnormalities of kidney function or structure that have been present for more than three months and can be categorised into five stages dependent on functionality of the kidney.13 Dialysis (a medical treatment used to artificially filter waste products and excess fluids from the blood when the kidneys are unable to perform this function adequately)14 or kidney transplantation is recommended for patients whose kidneys have reached an advanced stage (typically, stage 5).15 More than 60 per cent of adult patients diagnosed with IgA nephropathy are in CKD stage 3 or higher.6 Patients with this condition may experience blood in the urine (red or dark brown urine), foamy urine from protein leaking into the urine, flank pain, swelling (oedema), high blood pressure, and fatigue.16 About FILSPARI® (sparsentan) Sparsentan was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. Sparsentan is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialisation rights for sparsentan in Europe, Australia and New Zealand. Sparsentan is anticipated to be available to patients in the UK in the second half of 2025. Sparsentan is the first and only non-immunosuppressive treatment for IgA nephropathy that has two modes of action.1 This single molecule functions as a high affinity, dual-acting antagonist of both the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R).4 Sparsentan inhibits activation of both ETAR and AT1R, both of which play a role in regulating processes in the kidney, such as inflammation, that lead to progression of kidney damage.4 About PROTECT NICE's recommendation is based on data from the pivotal Phase 3 PROTECT study4 of sparsentan in IgA nephropathy, one of the largest interventional studies to date in IgA nephropathy and the only head-to-head trial in this rare kidney disease. It is a global, randomised, multicentre, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy.4,17 The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance.4 After 36 weeks of treatment, patients receiving sparsentan (n=202) achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients (n=202).4,17 Treatment emergent adverse events and serious adverse events were well-balanced between sparsentan and irbesartan, except for dizziness (30 [15%] vs 13 [6%] patients) and hypotension (26 (13%] vs eight (4%] patients).4 For more information, please refer to the Summary of Product Characteristics (SmPC).18,19 References: Trachtman H, et al. Sparsentan: the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy. Expert Rev Clin Immunol. 2024 Jun;20(6):571-576. doi: 10.1080/1744666X.2024.2319132. Komers R, et al. Dual inhibition of renin-angiotensin-aldosterone system and endothelin-1 in treatment of chronic kidney disease. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R877-84. doi: 10.1152/ajpregu.00425.2015. NICE Draft Final Guidance on sparsentan (May 2025). Rovin BH, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4. Travere Therapeutics and CSL Vifor Announce Standard EU Approval of FILSPARI® (sparsentan) for IgA Nephropathy; press release (April 2025). Pitcher D, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727– Reich HN, et al. Remission of proteinuria improves prognosis in IgA nephropathy. J Am Soc Nephrol. 2007;18:3177–83. Sharma S, et al. From Proteinuria to Fibrosis: An Update on Pathophysiology and Treatment Options. Kidney Blood Press Res. 2021;46:411−20. Bagchi S, et al. Supportive Management of IgA Nephropathy With Renin-Angiotensin Blockade, the AIIMS Primary IgA Nephropathy Cohort (APPROACH) Study. Kidney Int Rep. 2021 Feb 26;6(6):1661-1668. doi: 10.1016/ PMID: 34169207; PMCID: PMC8207308. European Medicines Agency (EMA). (2020) Orphan designation for the treatment of primary IgA nephropathy (accessed May 2025). Barratt J, et al. Therapy of IgA nephropathy: time for a paradigm change. Front Med (Lausanne). 2024 Aug 15;11:1461879. doi: 10.3389/fmed.2024.1461879. PMID: 39211339; PMCID: PMC11358106. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Disease, Kidney International (2021) 100, S1-S276 (accessed May 2025). NKF Kidney Disease Stages (accessed May 2025). NKF Haemodialysis (accessed May 2025). NKF Transplants for All Transplantation (accessed May 2025). Mayo Clinic What is IgA Nephropathy? (accessed May 2025). Heerspink HJL, et al. PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1. PMID: 37015244. Filspari EU131-SmPC_SPT_UK_200mg UK SmPC (May 2025). Filspari EU131-SmPC_SPT_UK_400mg UK SmPC (May 2025). CSL Vifor Media Contact Thomas Hutter+41 79 957 96 73media@ Job no: UK-SPT-25000110 Date: 23 May 2025 View original content to download multimedia: SOURCE Vifor International AG (CSL Vifor) View original content to download multimedia: Error 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
Irish Independent
16-05-2025
- Health
- Irish Independent
Kilkenny GAA star is on waiting list for life-changing kidney transplant – ‘To them you're not this sick person with this disease, you are just daddy'
Born and raised in Threecastles in Co Kilkenny where hurling is in the blood, Derek lived and breathed the game from the moment he could lift a hurl. Hurling was more than just a sport to Derek, it was his identity. That was until a routine work screening in 2018 discovered high levels of protein in his urine. This chance discovery marked the beginning of a long and difficult journey for Derek, a journey that he is still on to this day. At first, there was little cause for concern. Although he was referred to a nephrologist for annual check-ups, Derek's life continued on as normal. That was until 2023 when all sense of normality was shattered and came crashing down around him. A general check-up with his GP and follow up blood tests revealed a sharp decline in Derek's kidney function. Derek soon underwent a kidney biopsy which diagnosed Derek (37) with a chronic kidney disease called IgA Nephropathy, also known as Berger disease. IgA Nephropathy can occur when deposits of immunoglobin, a protein that fights bacteria in the body, builds up in the kidneys causing inflammation that can make it harder for the kidneys to filter waste from the blood. Within just a couple of months, Derek reached end-stage kidney disease. "To get that diagnosis was soul destroying,' Derek told The Irish Independent. 'I remember just bursting into tears. I had actually gone to the appointment by myself. I remember leaving the appointment and having to make that phone call to tell my wife, Anita, the news and I just burst into tears on the phone. "In that moment, you can't see any positivity. I was so sick. I had no energy, I couldn't eat and I was just exhausted all the time.' ADVERTISEMENT From playing hurling several nights a week and winning numerous county championships along with a few All-Irelands, Derek's life was flipped completely upside down as he had a fistula inserted into his arm to begin dialysis treatment in May of 2024. Three days a week, on Mondays, Wednesdays and Fridays, Derek is up before the sun has even risen to catch a 50-minute HSE taxi ride to University Hospital Waterford for his 7.30am dialysis treatment. The dialysis treatment takes its toll on Derek's body, leaving him completely exhausted after the four hour treatment finally comes to an end. Despite this, Derek remains positive, describing it as only a 'small little blip' in his journey. "Four hours might sound long, but I try to remain positive and not let it consume my life,' said Derek. 'If you think about it, it's only four hours three days a week. All the other hours in the week I get to spend it either with my family or my friends or with sport so it's only a small little blip on the journey.' Despite being on dialysis treatment three days a week, Derek still finds time and energy for his work as a calibration engineer. "Tiredness is a constant, but it's part of the routine so I still try to keep busy. Being busy is like my coping mechanism. I work on my laptop while I'm in the hospital having dialysis. It helps pass the time and keep a sense of normality for me. My employer is very understanding.' Derek is also kept busy outside of work. Although the kidney disease forced Derek to give up playing hurling, he refused to give up his love for the sport. Now involved in coaching hurling, Derek is part of the management team for his local club, Threecastles, who won the county title and then went one better with a Leinster Championship under Derek's guidance. He also manages to find time in his hectic schedule to coach the Blacks & Whites intermediate hurling team in Skeoughvosteen. Although originally from Threecastles, Derek now lives in Graiguenamanagh in Co Kilkenny with his wife, Anita, and their two daughters, Méabh, who is 20-months-old and baby Róisín, who is just five-months-old. For Derek, Anita and their two girls have been his rock throughout this journey. 'My wife and the two girls mean the absolute world to me. They give me the strength to keep going. "It can be a handful with a 20-month-old and a five-month-old in the house but they make me feel normal. To them you are just daddy, you're not this sick person with this disease, you are just daddy. "I keep using this word 'normal', but looking after my two girls does make me feel normal and healthy again because I'm doing something that a normal healthy person does.' Derek doesn't hide the fact that his dialysis journey took a toll on his mental health. 'I was struggling,' he said. 'I needed help and I got it. "Taking part in the Peer Support Programme run by the Irish Kidney Association gave me a connection to others who also faced a similar health journey to me.' Derek is now an ambassador for the Irish Kidney Association's Peer Support Programme as he wants to encourage others to talk about and mind their mental health, just as much as their physical health. He added that men in particular must look after themselves and go to the doctor if they have any concerns as men can typically shy away from talking about their physical and mental health as a result of the stigmas attached. Dialysis has had a massive impact on Derek's life and the lives of his two daughters and his wife. But having an end goal of getting a new kidney, means Derek can view the dialysis as a means to an end. 'I had to learn to accept that I was sick, but having the end goal of getting a kidney transplant means there is a light at the end of the tunnel for me. "Getting a transplant would mean coming off dialysis and getting back some sense of a normal life. "I have been on a waiting list for a kidney transplant for nearly a year at this stage. I've been told that for my blood group, there is an average waiting list of about two years for a kidney transplant. 'Whenever I do get that call that they have a kidney for me, I need to be ready to go straight away to Beaumont Hospital. I already have a bag packed by the front door in case I get that call.' To mark Organ Donor Awareness Week, Derek is sharing his story to help others understand what kidney failure means and the impact it has on the lives of those who are sick and also on their loved ones. Derek hopes that if someone hears his story, it might inspire them to have that all-important conversation about organ donation. "The amount of people on a waiting list for a kidney transplant in this country is frightening,' said Derek. 'For the likes of myself and the hundreds of people who go into dialysis each day across the country, we are waiting for that life-changing kidney that will basically continue our lives. "It is so important to have a conversation with your family, friends or loved ones about organ donation and your wishes to be a donor if the worst was to happen. That one conversation could change everything for families like mine. "As an organ donor, you are saving lives.' Next month, a major change in the law surrounding organ donation will come into effect. From June 17, when a person dies, it will automatically be assumed they wish to donate their organs, unless they have indicated an objection during their lifetime. The soft opt-out is expected to increase the donor pool of organs for over 600 people on the transplant list. "This law change is a massive positive step forward,' said Derek. 'I know myself, before I got sick, organ donation would never have crossed my mind. "Because I never thought about organ donation, if the worst did happen, I would have two kidneys that I couldn't give to someone. "Now if I wasn't sick, it is reassuring to know I would automatically be on the organ donor list and if the worst was to happen to me, I would still be saving and changing lives for the better. "I would also say, to still have a conversation with your loved ones about organ donation,' he added. 'Because unfortunately, if anything did happen to you, it is again down to your next-of-kin as well.' For now, Derek must continue his four hours of dialysis, three days a week. But with a bag already packed and waiting by the front door, Derek knows that a new life, without the all-consuming presence of dialysis, is just around the corner.
Globe and Mail
13-05-2025
- Health
- Globe and Mail
Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals
The Key IgA Nephropathy Companies in the market include - Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others. DelveInsight's 'IgA Nephropathy Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the IgA Nephropathy, historical and forecasted epidemiology as well as the IgA Nephropathy market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. Some of the key facts of the IgA Nephropathy Market Report: The IgA Nephropathy market size was valued approximately USD 730 million in 2024 and is anticipated to grow with a significant CAGR during the study period (2020-2034) In March 2025, Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced topline findings from Part 2 of its Phase 1/2 clinical trial evaluating ARO-C3, an investigational RNA interference (RNAi) therapy aimed at lowering liver production of complement component 3 (C3) to potentially treat multiple complement-mediated disorders. In November 2024, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical Co., Ltd. have announced plans to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational therapy for adult patients with immunoglobulin A nephropathy (IgA nephropathy), in the first half of 2025. This decision follows a recent meeting with the U.S. FDA to review the positive interim findings from the Phase 3 VISIONARY trial (NCT05248646). In January 2024, Vera Therapeutics, Inc. (Nasdaq: VERA), a biotechnology company in the advanced stages of clinical development focused on innovative treatments for individuals with severe immunologic conditions, announced today the addition of two seasoned industry professionals to spearhead the advancement of the company's drug initiatives. This includes their late-stage candidate, atacicept, presently undergoing a Phase 3 clinical trial for IgA nephropathy (IgAN). Effective immediately, Robert M. Brenner, M.D., assumes the role of Chief Medical Officer, succeeding Dr. Celia Lin, M.D., while William D. Turner takes on the position of Chief Development Officer. In 2024, the market size for IgA Nephropathy (IgAN) in the US was around USD 455 million and is expected to grow with the introduction of emerging therapies. The total market size for the EU4 and the UK was estimated at around USD 150 million in 2024, representing nearly 21% of the overall market revenue for the 7MM, with growth expected by 2034. In 2024, Germany led the IgAN market among the EU4 and the UK with approximately USD 45 million in revenue, followed by France at around USD 35 million and Italy at nearly USD 30 million. In 2024, Japan's IgAN market size was estimated at around USD 125 million, with expectations of growth throughout the forecast period from 2025 to 2034. DelveInsight estimates that around 415,000 prevalent cases of IgA Nephropathy (IgAN) were reported across the 7MM in 2024. These diagnosed cases are expected to grow at a CAGR of 0.6% by 2034. In 2024, the United States reported approximately 133,000 diagnosed prevalent cases of IgA Nephropathy (IgAN), with numbers expected to rise by 2034. In 2024, Germany had the highest number of diagnosed prevalent cases of IgA Nephropathy (IgAN) among the EU4 and the UK, with approximately 30,000 cases, while Spain had the lowest, with around 5,000 cases. In 2024, Japan reported the highest number of diagnosed prevalent cases of IgA Nephropathy (IgAN) among the 7MM, with nearly 175,000 cases, and this number is projected to increase by 2034. In 2024, France reported around 16,000 diagnosed prevalent cases of IgA Nephropathy (IgAN) in males and 8,000 in females, with both numbers anticipated to increase by 2034. Key IgA Nephropathy Companies: Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others Key IgA Nephropathy Therapies: VANRAFIA (atrasentan), FILSPARI (sparsentan), TARPEYO/KINPEYGO (budesonide), Povetacicept (ALPN-303), Atacicept, Zigakibart (FUB523), Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others The IgA Nephropathy epidemiology based on gender analyzed that IgAN is more prominent in males in comparison to females. Prevalence of IgAN occurs in men around two times more than females worldwide. The IgA Nephropathy market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage IgA Nephropathy pipeline products will significantly revolutionize the IgA Nephropathy market dynamics. IgA Nephropathy Overview IgA nephropathy, also known as Berger's disease, is a kidney disorder characterized by the buildup of the antibody immunoglobulin A (IgA) in the kidneys. This buildup can lead to inflammation and damage to the tiny filters in the kidneys called glomeruli. IgA nephropathy is one of the most common forms of glomerulonephritis, which is inflammation of the glomeruli. IgA Nephropathy Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. IgA Nephropathy Epidemiology Segmentation: The IgA Nephropathy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalence of IgA Nephropathy Prevalent Cases of IgA Nephropathy by severity Gender-specific Prevalence of IgA Nephropathy Diagnosed Cases of Episodic and Chronic IgA Nephropathy Download the report to understand which factors are driving IgA Nephropathy epidemiology trends @ IgA Nephropathy Epidemiology Forecast IgA Nephropathy Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the IgA Nephropathy market or expected to get launched during the study period. The analysis covers IgA Nephropathy market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the IgA Nephropathy Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. IgA Nephropathy Therapies and Key Companies VANRAFIA (atrasentan): Novartis FILSPARI (sparsentan): Travere Therapeutics TARPEYO/KINPEYGO (budesonide): Asahi Kasei (Calliditas Therapeutics) Povetacicept (ALPN-303): Vertex Pharmaceuticals Atacicept: Vera Therapeutics Zigakibart (FUB523): Novartis Sibeprenlimab: Visterra Atrasentan: Chinook Therapeutics LNP023: Novartis Pharmaceuticals Research programme: IgA proteases Selecta Biosciences AP 305: Shanghai Alebund Pharmaceuticals ADR-001: Rohto Pharmaceutical MY 008: Wuhan Createrna Science and Technology SHR-2010: Guangdong Hengrui Pharmaceutical IONIS FB: LRx Ionis Pharmaceuticals HR19042: Jiangsu HengRui Medicine Co., Ltd. Sparsentan: Travere Therapeutics HR19042: Jiangsu HengRui Medicine Co., Ltd. Discover more about therapies set to grab major IgA Nephropathy market share @ IgA Nephropathy Treatment Landscape IgA Nephropathy Market Drivers Increase in prevalence of IgA Nephropathy (IgAN), increment in the number of government initiatives to spread awareness are some of the important factors that are fueling the IgA Nephropathy Market. IgA Nephropathy Market Barriers However, lack of in-depth understanding of the disease pathogenesis, the unreported and undiagnosed IgA Nephropathy cases and other factors are creating obstacles in the IgA Nephropathy Market growth. Scope of the IgA Nephropathy Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key IgA Nephropathy Companies: Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others Key IgA Nephropathy Therapies: VANRAFIA (atrasentan), FILSPARI (sparsentan), TARPEYO/KINPEYGO (budesonide), Povetacicept (ALPN-303), Atacicept, Zigakibart (FUB523), Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others IgA Nephropathy Therapeutic Assessment: IgA Nephropathy current marketed and IgA Nephropathy emerging therapies IgA Nephropathy Market Dynamics: IgA Nephropathy market drivers and IgA Nephropathy market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies IgA Nephropathy Unmet Needs, KOL's views, Analyst's views, IgA Nephropathy Market Access and Reimbursement Table of Contents 1. IgA Nephropathy Market Report Introduction 2. Executive Summary for IgA Nephropathy 3. SWOT analysis of IgA Nephropathy 4. IgA Nephropathy Patient Share (%) Overview at a Glance 5. IgA Nephropathy Market Overview at a Glance 6. IgA Nephropathy Disease Background and Overview 7. IgA Nephropathy Epidemiology and Patient Population 8. Country-Specific Patient Population of IgA Nephropathy 9. IgA Nephropathy Current Treatment and Medical Practices 10. IgA Nephropathy Unmet Needs 11. IgA Nephropathy Emerging Therapies 12. IgA Nephropathy Market Outlook 13. Country-Wise IgA Nephropathy Market Analysis (2020–2034) 14. IgA Nephropathy Market Access and Reimbursement of Therapies 15. IgA Nephropathy Market Drivers 16. IgA Nephropathy Market Barriers 17. IgA Nephropathy Appendix 18. IgA Nephropathy Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. 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