NVS Novartis AG

   By Joshua Kirby 
 

Novartis AG said Wednesday that its drug Vijoice (alpelisib) has been granted accelerated approval in the U.S. for the treatment of adults and children with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

The U.S. Food & Drug Administration gave the approval to Vijoice for adults and children above two years of age suffering from the PROS, a spectrum of rare conditions characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system and other tissues, the Swiss drugmaker said.

The accelerated approval program means continued approval may be contingent upon proof of clinical benefit from confirmatory evidence, Novartis said.

Write to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby

(END) Dow Jones Newswires

April 06, 2022 01:17 ET (05:17 GMT)

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