Author Archives: Alex Shimmings

Novartis close to EU approval for Zolgensma at last

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU. After several delays plus a row over a controversial lottery-style managed access program in Europe, Novartis gene therapy Zolgensma (onasemnogene abeparvovec) has finally been granted a positive opinion by the EU’s Committee for Medicinal Products for Human Use (CHMP). The committee has recommended a conditional marketing authorization of Zolgensma for the…