Novartis’ Zolgensma Faces ‘Manufacturing Questions’ in EU
Novartis CEO Vas Narasimhan said that the company faces additional “manufacturing questions” from the EU regarding its gene therapy product Zolgensma (onasemnogene abeparvovec-xioi).
Narasimhan said that the company has filed responses with the European Medicines Agency and is working to ensure a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
The committee is expected to give an opinion on Zolgensma for treatment of infant spinal muscular dystrophy in the first quarter of 2020. Japan is expected to issue a decision on the drug in the first half of 2020.