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

10 February 2023 | Friday | News

Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines in Greater China and other parts of Asia, announced today that South Korea's Ministry of Food and Drug Safety (MFDS) has granted Global Innovative product on Fast Track (GIFT) designation to Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN)
Image Source : Public Domain

Image Source : Public Domain

This demonstrates the urgent unmet medical needs for Nefecon, as Everest also received Priority Review status for the New Drug Application (NDA) of Nefecon in China from the National Medical Products Administration (NMPA).

Nefecon is the second product and the first non-oncology product included in MFDS' GIFT program. Inclusion in the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review.

"We are excited to see South Korea MFDS' designation of GIFT for Nefecon, which will significantly accelerate the review process for this first-in-disease therapy in Asia's third-largest pharmaceutical market," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "IgAN has much higher prevalence in East Asia than the rest of the world and we hope to bring this novel therapy to this region and address unmet patient needs as soon as possible."

South Korea's MFDS also granted ODD[i] status for Nefecon in November 2022 while the Taiwan Food and Drug Administration awarded Accelerated Approval Designation (AAD) to Nefecon in the same month.

Renal disease is one of the core therapeutic areas for Everest Medicines with Nefecon as the leading product. The company is also developing a promising pipeline with the potential to treat glomerular diseases.

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