The European Medicines Agency (EMA) has recommended suspending the marketing authorization for Pfizer's sickle cell disease drug, Oxbryta. This recommendation follows Pfizer's voluntary withdrawal of the therapy from all markets due to safety concerns.
European regulators noted that patients in trials experienced higher rates of pain crises after starting treatment with Oxbryta compared to before taking the drug. This finding contributed to the EMA's decision, aligning with Pfizer's assessment that the overall benefit no longer outweighs the risk.
The EMA's recommendation reinforces the global regulatory scrutiny and safety concerns surrounding Oxbryta. This action further solidifies the cessation of the drug's availability in a major international market, impacting Pfizer's product portfolio.
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