BASEL (dpa-AFX) - Novartis (NVS, NOVN.SW) announced that the European Commission has approved Itvisma or onasemnogene abeparvovec for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy with a bi-allelic mutation in the survival motor neuron 1 gene. The approval is based on data from the registrational STEER study, and supportive Phase IIIb STRENGTH and Phase I/II STRONG studies.
The company noted that, with this approval, Itvisma becomes the first and only gene replacement therapy currently approved for this broad SMA population in the European Union.
At last close, Novartis shares were trading at 125.00 Swiss francs, down 1.25%.
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