CHMP decisions set stage for approval of Novartis’ SMA gene therapy, Celgene’s Zeposia for MS, Sanofi’s comeback cancer drug

EMA’s CHMP backed conditional approval of an MAA for Zolgensma to treat spinal muscular atrophy in its March set of recommendations, which were made via a virtual meeting because of the COVID-19 outbreak. The agency also recommended that the EC approve two other closely watched therapies: Celgene multiple sclerosis drug Zeposia, a key piece in the company’s acquisition by BMS, and Sanofi’s Sarclisa, which became the pharma’s first cancer drug to be approved in more than a decade after its FDA approval March 2.

The agency suggested conditional marketing authorization of Zolgensma onasemnogene abeparvovec, from the AveXis Inc. unit of Novartis AG (NYSE:NVS; SIX:NOVN), to treat “babies and young children” with SMA caused by bi-allelic loss-of-function mutations in SMN1 and either diagnosed with Type I SMA or having up to three copies of the SMN2 gene...