By Fineline Cube 
The China unit of Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that the National Medical Products Administration (NMPA) has approved an additional indication for its oral monotherapy Fabhalta (iptacopan). The expanded approval now includes the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were previously treated with complement inhibitors, providing a new therapeutic option for this patient population.
Fabhalta’s Regulatory Milestone in China
Fabhalta, the world’s first oral, targeted factor B inhibitor of the complement system, now boasts three approved indications in China. These include adult PNH patients who were previously untreated with complement inhibitors and adult patients with C3 glomerulopathy (C3G). This latest approval underscores the drug’s growing role in the treatment landscape for complement-mediated diseases.
Ongoing Development and Future Prospects
Novartis continues to develop Fabhalta for a range of complement-mediated conditions beyond PNH and C3G. The drug is currently under investigation for potential applications in atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN), and lupus nephritis (LN), further highlighting its broad therapeutic potential.-Fineline Info & Tech