Novartis' Iptacopan Capsules for C3 Glomerulopathy in Adults Granted Priority Review in China
Novartis
Drug Development and Manufacturing
On September 23, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Novartis' Iptacopan Hydrochloride Capsules New Indication Marketing Application Proposed for Priority ReviewThe indication is for adult patients with C3 glomerulopathy (C3G). Outside of China, the drug has not yet been submitted for marketing approval for this indication in other countries.
Source of the image:Website of the Center for Drug Evaluation, National Medical Products Administration of China
Iptacopan is an oral CFB inhibitor under research by Novartis.In April this year, Eculizumab was approved for the first time in China for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Currently, Iptacopan has been approved globally for two indications: paroxysmal nocturnal hemoglobinuria and IgA nephropathy. Among them, paroxysmal nocturnal hemoglobinuria has been approved in China, and IgA nephropathy was submitted for marketing in China on August 7 this year.The C3 glomerulopathy submitted for regulatory approval in China this time is the world's first marketing application, with progress leading globally.
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