EMA Suspends Marketing Authorization for Pfizer’s Oxbryta

(Reuters) – The European Medicines Agency (EMA) recommended suspending the marketing authorization for Pfizer’s sickle cell disease drug, Oxbryta, on Thursday.

The EMA stated that new data raises serious concerns regarding the safety of Oxbryta. Consequently, it has advised that the authorization, marketing, and supply of the drug be suspended until all available data can be evaluated in the ongoing review process.

On Wednesday, Pfizer announced it would withdraw Oxbryta from all markets where it is currently approved, citing risks of painful complications and potential deaths associated with the drug.