Calliditas Therapeutics AB today announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed-release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ?1.5g/g. This indication is approved under accelerated approval. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
The overall incidence of the USA is 1.2 to 2.5 per 100,000 whereas in Europe the incidence rate is to be found 0.78 to 1.9 cases per 100,000 populations. In the children, the incidence in a Japanese biopsy registry study where broad screening programs were in place was eightfold higher compared with a Tennessee program where biopsies were performed for cause and routine screening was not and found 4.5 versus 0.57 per 100,000 per year. The prevalence of IgAN differs greatly between geographic locations, being 29.2% of the biopsied population in Asia, 12% in Australia, 10.7% in Europe, and 5% in North America
Comprehensive insight on patient segmentation based on types (Primary IgAN and Secondary IgAN), Coexisting conditions (Bloody Urine, High Blood Pressure, AKI, CKI, ESRD, and others), and clinical manifestations has been provided into the epidemiology (Incidence and Prevalence) section of the IgA Nephropathy and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China
In terms of pharmacologic therapies, Several drug candidates are in Phase II and II/ III stages of development by various companies. Key assets among these are, Narsoplimab; Omeros Corporation, Nefecon; Calliditas Therapeutics, Sparsentan; Retrophin, Inc., ALN-CC5; Alnylam Pharmaceuticals, Inc., Astagraf XL; Astellas Pharma, Atacicept; Merck KGaA, Blisibimod; Anthera Pharmaceuticals, LNP023; Novartis AG, Tavalisse; Rigel Pharmaceuticals, BI-ON-1301; Aduro Biotech, VIS649; Otsuka Holdings. Among these key assets, some of the assets are being designated as orphan drugs and fast track. The launch of key assets will positively impact the overall market from 2020 to 2030 in 8 MM countries. While there is a lot of competitive activity going on in the pipeline for IgA Nephropathy, European regulators have granted a fast path to market for Calliditas Therapeutics’ potential rare kidney dis-ease drug, Nefecon, weeks after a similar decision by the FDA. Apart from the above development the extended data from the Phase II cohort study strongly support the potential efficacy of OMS721 in IgA nephropathy from Narsoplimab; Omeros Corporation
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