China’s NMPA accepts Everest Medicines’ Nefecon supplementary application
Betsy Goodfellow | July 18, 2024 | News story | Medical Communications | China, Everest Medicines, NMPA, Nephrology
Everest Medicines has announced that China’s National Medical Products Administration (NMPA) has accepted the submission of a supplemental New Drug Application (sNDA) seeking full approval of Nefecon based on new clinical data from its phase 3 NeflgArd study.
The drug is expected to become the first-in-disease IgA nephropathy (IgAN) treatment to gain full NMPA approval. It was first approved in November 2023 under China’s NMPA’s accelerated approval pathway for the treatment of adult patients at risk of disease progression in primary IgAN.
The US Food and Drug Administration (FDA) has also approved Nefecon delayed release capsules for adults with primary IgAN who are at risk of disease progression, regardless of proteinuria levels.
Rogers Yongqing Luo, chief executive officer at Everest Medicine, commented: “NMPA’s acceptance of the submission of Nefecon sNDA further demonstrates the innovative advantages of this first-in-disease treatment for IgAN. IgAN is prevalent in the Asian population, which has 56% higher risk of progression to end-stage renal disease and faster disease progression. Since launching in China in May, Nefecon has already opened a new era of IgAN treatment. With approximately five million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. Nefecon has undergone a 20-year research and development process and become the first approved medicine with the IgAN indication by the NMPA. It is also the first fully FDA-approved treatment for adults with primary IgAN who are at risk for disease progression, irrespective of proteinuria levels. We look forward to working closely with the regulatory authority to bring this innovative treatment to all IgAN patients in China soon.”
Betsy Goodfellow
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