Critical Juncture In Zolgensma EU Market Quest
Expensive And Controversial Gene Therapy Reaches CHMP
Executive Summary
If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months.
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AveXis/Novartis’s one-time AAV9 vector-based intravenous gene therapy for spinal muscular atrophy, Zolgensma, continues to have beneficial effects up to five years after its administration to babies, and an intrathecal formulation has significant promise in older infants.