Novartis receives third FDA approval for oral Fabhalta

The US Food and Drug Administration (FDA) has approved Swiss pharma giant Novartis’ (NOVN: VX) oral Fabhalta (iptacopan) for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition and the third US indication for the drug.

“C3G is a debilitating disease often affecting young people, impacting many aspects of their physical and emotional health, and our previous treatment options came with significant challenges,” said Dr Carla Nester, professor of pediatrics-nephrology at the University of Iowa and Fabhalta APPEAR-C3G study co-investigator. “This approval of Fabhalta is historic for the entire C3G community as now, for the first time, we have a therapy that is believed to treat the underlying cause of the disease, providing the potential for a new standard of care for patients,” she added.

Novartis noted that Fabhalta is the only oral inhibitor of the alternative complement pathway to selectively target what is thought to be the underlying cause of the disease. Before the approval of Fabhalta, patients had to rely on supportive care, broad immunosuppression, and symptom management.