Critical Juncture In Zolgensma EU Market Quest
Expensive And Controversial Gene Therapy Reaches CHMP
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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Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.
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.