Latest news with #Nefecon
Yahoo
09-06-2025
- Health
- Yahoo
Calliditas Therapeutics Presented at the 62nd European Renal Association Congress
STOCKHOLM, June 9, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that new data was presented at the 62nd European Renal Association Congress (ERA Congress), which took place in Vienna, Austria, from June 4 to 7. The presentations included secondary analyses and new insights from biomarker from the Phase 3 NefIgArd study of Nefecon (marketed as TARPEYO® [budesonide] delayed-release capsules in the United States in patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression and Kinpeygo® in Europe for the treatment of adults with primary immunoglobulin A nepropathy (IgAN) with a urine protein excretion ≥ 1.0g/day (or urine protein-to-creatinine ration ≥ 0.8g/g) and in the United Kingdom for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/gram). A total of five abstracts were accepted for presentation, including one selected as a Top 10 abstract for oral presentation, along with four additional focused oral presentations. Oral Presentation Details Abstract No. 3345 – Selected as a Top 10 AbstractTitle: "Nefecon provides kidney benefit irrespective of baseline eGFR in patients with IgAN: A subanalysis of the NefIgArd study"Presenter: Jonathan Barratt, United Kingdom Focused Oral Presentation Details Abstract No. 3251Title: "Nefecon provides kidney benefit irrespective of time since diagnosis in patients with IgAN: A subanalysis of the NefIgArd study"Presenter: Richard Lafayette, United States Abstract No. 3337Title: "The NefXtend trial, investigating extended Nefecon treatment beyond 9 months in patients with IgAN"Presenter: Richard Lafayette, United States Abstract No. 2642Title: "Effects of Nefecon on Hits 1, 2, and 3 of the pathogenic cascade of IgA nephropathy: A full NefIgArd analysis"Presenter: Ishika Khan, United Kingdom Abstract No. 2651Title: "Sustainability and depth of UPCR reduction in patients with primary IgAN treated with Nefecon: A secondary analysis of the Phase 3 NefIgArd trial"Presenter: Jonathan Barratt, United Kingdom The ERA Congress is a leading international event focused on kidney health and renal science. Organized by the European Renal Association, the 2025 Congress brought together nephrologists, researchers, and healthcare professionals from across the globe for scientific sessions, interactive workshops, and networking opportunities. The event aimed to advance research, clinical care, and innovation in nephrology. About TARPEYO®/Kinpeygo®TARPEYO® is an oral 4mg delayed-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1), causing IgA nephropathy. About Primary Immunoglobulin A NephropathyPrimary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage, potentially resulting in end-stage kidney disease. IgAN most often develops between late teens and late 30s. About CalliditasCalliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit for further information. About Asahi KaseiThe Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Healthcare. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit View original content to download multimedia: SOURCE Asahi Kasei Corporation 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
Medscape
06-06-2025
- Health
- Medscape
Nefecon Shows IgAN Benefits Regardless of Baseline eGFR
Nefecon, an oral targeted-release formulation of budesonide that targets drug release into the distal ileum, provided significant improvements in the loss of kidney function in patients with immunoglobulin A nephropathy (IgAN) at 9 months, regardless of baseline estimated glomerular filtration rate (eGFR) status, according to a new subanalysis of the phase 3 NeflgArd study. METHODOLOGY: Patients in the NeflgArd study with primary IgAN were randomly assigned to one of two groups of 182 patients each to receive either treatment with 16 mg Nefecon or placebo daily, along with supportive care with renin-angiotensin system inhibition. This was followed by a 15-month off-drug observational period allowing for continued supportive care. For the subanalysis, the patients were further stratified on the basis of eGFR deciles in relation to the overall study population, with levels above and below 38, 43, 47, 51, 55, 60, 66, 72, and 82 mL/min/1.73 m 2 . . The median eGFR overall was 55.49 mL/min/1.73 m2 and was balanced across the Nefecon and placebo groups. TAKEAWAY: The relative benefit of Nefecon in terms of eGFR was seen across most deciles and timepoints and showed a generally greater benefit in higher baseline eGFR groups (above 72 mL/min/1.73 m 2 ). ). Furthermore, the relative urine protein-creatinine ratio benefit was observed from month 9 with Nefecon vs placebo regardless of baseline eGFR, with a continued reduction to month 12, followed by a maintained treatment benefit to month 24. The eGFR benefits with Nefecon over placebo were observed among patients within the upper and lower deciles over 2 years. eGFR showed a pronounced on-treatment benefit and a delay in decline during the observation period. IN PRACTICE: 'This NefIgArd subanalysis demonstrated that the efficacy of a 9-month Nefecon treatment course in reduction of proteinuria and preservation of kidney function was independent of baseline eGFR,' said first author Jonathan Barratt, MD, of the College of Life Sciences, University of Leicester, UK. 'So, we should be confident about treating people with Nefecon across the full range of eGFR in terms of the eGFR saving we're going to see, but also the proteinuria reduction,' he added. SOURCE: The findings were reported this week at the 62nd European Renal Association (ERA) Congress 2025. DISCLOSURES: The study was funded by Calliditas Therapeutics AB. Credit Lead image: Medscape Medscape Medical News © 2025 WebMD, LLC Cite this: Nefecon Shows IgAN Benefits Regardless of Baseline eGFR - Medscape - June 06, 2025.
