“Based on the information available at this time, the Phase 3 clinical trial results continue to provide compelling evidence of the effectiveness of Zolgensma, along with sufficient evidence of safety to support an overall favorable benefit-risk profile,” Bryan wrote. Novartis said AveXis could face a civil or criminal penalty after the US FDA said the Swiss firm manipulated preclinical data for spinal muscular replacement gene therapy trials . It was allegedly aware data from in vivo mouse studies had been manipulated on 14 March , but waited until more than a year after Zolgensma had been approved to notify the FDA , according to a memo . The Administration said the overall data supported the drug remaining on the market .
Novartis said AveXis could face a civil or criminal penalty after the US FDA said the Swiss firm manipulated preclinical data for spinal muscular replacement gene therapy trials . It was allegedly aware data from in vivo mouse studies had been manipulated on 14 March , but waited until more than a year after Zolgensma had been approved to notify the FDA , according to a memo . The Administration said the overall data supported the drug remaining on the market .