FDA approves Novartis Vijoice for PIK3CA-related overgrowth spectrum

Swiss pharma giant Novartis (NOVN: VX) today announced the US Food and Drug Administration has granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million. In accordance with the Accelerated Approval Program, continued approval may be contingent upon verification and description of clinical benefit from confirmatory evidence.

Novartis’ shares edged up 1% to 82.92 francs on the news.