EMA recommends suspension of sickle cell disease medicine Oxbryta

EMA

26 September 2024 - The EMA’s CHMP has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a review of emerging data is on-going.

The recommendation follows emerging safety data from two registry-based studies, which indicate that patients in the studies had a higher occurrence of vaso-occlusive crises during treatment with Oxbryta than they did before starting the medicine.

Read EMA press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Regulation