Pfizer (PFE) said late Wednesday it is 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 said it is also discontinuing all active voxelotor clinical trials and expanded access programs globally.
The data shows an imbalance in vaso-occlusive crises and fatal events requiring further assessment, Pfizer said, adding that it has notified regulatory authorities of its decision to withdraw Oxbryta from the market and to discontinue distribution and clinical studies while it investigates these findings.
Pfizer said it does not expect this decision to impact its full-year 2024 financial guidance.
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