Novartis offers pledge after Zolgensma data issue

Swiss pharma giant Novartis (NOVN: VX) has responded to the US Food and Drug Administration’s (FDA) issuing of a Form 483 relating to allegations of data manipulation on Zolgensma (onasemnogene abeparvovec-xioi).

Developed by Novartis’ AveXis unit, this product is the first approved gene therapy to treat children of less than two years with spinal muscular atrophy, a leading cause of infant mortality.

FDA notified of allegations after approval