Pfizer Inc. announced its voluntary withdrawal of all lots of Oxbryta (voxelotor), its therapy for sickle cell disease, from all markets where it is approved. The decision is based on the totality of clinical data, which now indicates that the overall benefit of Oxbryta no longer outweighs the risk for the approved patient population.
The company's review of available data suggested an imbalance in vaso-occlusive crises and fatal events among patients treated with Oxbryta, necessitating further assessment. Pfizer has informed regulatory authorities of these findings and its decision to discontinue distribution and all active voxelotor clinical trials and expanded access programs worldwide.
Oxbryta was a central component of Pfizer's approximately $5.4 billion acquisition of Global Blood Therapeutics in 2022. The withdrawal of this drug, which generated $328 million in sales last year, raises questions about the long-term value of that acquisition and Pfizer's broader strategy for its sickle cell disease pipeline.
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