Novartis’ Zolgensma joins growing list of medicines to lose accelerated assessment status in EU
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program.
CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather than the accelerated 150 days. Novartis confirmed that its gene therapy is now under standard approval.
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