Novartis' (NVS.US) "potential blockbuster" oral new drug application for a new indication in China

The National Medical Products Administration's (NMPA) Center for Drug Evaluation's (CDE) website has recently announced that Novartis (NVS.US) has received approval for its new indication application for ipicopan capsules. The specific indication has not been disclosed. Ipicopan is a specific oral complement factor B inhibitor. It was approved for its first indication in China in April this year, used to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH). This is the third application for the product in China, and public information speculates that the indication may be C3 glomerulopathy.