Everest Medicines Announces South Korea Grants Fast-Track Review Designation to Nefecon for Primary IgA Nephropathy Treatment

Everest Medicines, a biopharmaceutical company developing and commercializing innovative pharmaceuticals and vaccines in Asia, has received Global Innovative product on Fast Track (GIFT) designation from South Korea’s Ministry of Food and Drug Safety (MFDS) for Nefecon, a treatment for primary immunoglobulin A nephropathy (IgAN).

Publish Date: 10-02-2023 Source: Everest Medicines

IgA nephropathy (IgAN) is the most common type of primary glomerulonephritis in the world. The primary defect of the disease is systemic aberrant glycosylation of Olinked glycans (glycoproteins) in the hinge region of IgA1, resulting in elevated serum levels of galactose-deficient IgA1 (GdIgA1), which is recognised by glycan-specific IgA and IgG autoantibodies. IgA is an antibody that plays an important part in mucosal immunity. IgA exists as two isotypes, IgA1 and IgA2, and can exist in a dimeric form called secretory IgA. Secretory IgA is produced by plasma cells predominantly in the polymeric form that consists of two or more monomers linked by the J-chain (a 17kDa polypeptide connecting two or more monomeric IgA). The kidney is the target of injury in IgAN; the disease takes a slow but relentless clinical course that eventually results in end-stage renal disease (ESRD) in 30–40% of patients within 20–30 years. IgAN can occur in either sporadic (90–95%) or familial (5–10%) patterns. Patients with familial IgAN may have a worse prognosis than those with sporadic disease, as they are more likely to progress to renal failure.

The prevalence of primary glomerulonephritis is low in the United States (10-20%), higher in some European countries (20-30%), and highest in developed Asian countries (40-50%).

However, the current IgA Nephropathy treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (LNP023, Nefecon, Sibeprenlimab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the IgA Nephropathy treatment. The key companies in the advanced development stage are Novartis Pharmaceuticals, Calliditas Therapeutics AB, Otsuka Pharmaceutical Development & Commercialization, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on IgA Nephropathy to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

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