12:50 PM EDT, 09/26/2024 (MT Newswires) -- The European Medicines Agency said Thursday its human medicines committee has recommended suspending a marketing authorization for Pfizer's ( PFE ) Oxbryta due to emerging safety concerns.

Pfizer ( PFE ) said late Wednesday it was voluntarily withdrawing all lots of Oxbryta, or voxelotor, for sickle cell disease treatment in approved markets due to clinical data showing that the drug's benefit no longer outweighs the risk. Pfizer ( PFE ) said it was also discontinuing all active voxelotor clinical trials and expanded access programs globally.

Recent data from registry-based studies indicated a higher occurrence of vaso-occlusive crises in patients treated with Oxbryta compared to prior treatment, the European Medicines Agency said. This review follows earlier findings that showed increased mortality rates associated with Oxbryta, it added.

Healthcare professionals are advised not to initiate treatment with Oxbryta and to discuss alternative options with current patients, the agency said.

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