EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug

The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.

Concept of EMA European Medicines Agency. Drugs evaluation and quality control.
The EMA has recommended revoking the EU approval for Adakveo • Source: Shutterstock

Novartis has expressed disappointment over a recommendation by the European Medicines Agency to revoke the EU conditional marketing authorization (CMA) for its sickle cell disease drug, Adakveo (crizanlizumab), because the product had failed to meet one of the specific obligations of the conditional approval.

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