Pfizer to Withdraw Sickle Cell Treatment Oxbryta Globally
Pfizer Inc. is voluntarily withdrawing all lots of its sickle cell disease (SCD) treatment, Oxbryta® (voxelotor), from worldwide markets. The company is also discontinuing all active clinical trials and expanded access programs for the drug.
NEW YORK – Pfizer Inc. announced Wednesday its decision to voluntarily withdraw all lots of Oxbryta® (voxelotor) from global markets where it is approved for the treatment of sickle cell disease (SCD). The pharmaceutical giant is also halting all ongoing clinical trials and expanded access programs related to voxelotor.
The company stated that the withdrawal is based on a review of clinical data indicating that the drug's benefits no longer outweigh the risks for the approved patient population. This assessment stems from data suggesting an imbalance in vaso-occlusive crises and fatal events that require further evaluation.
Pfizer has notified regulatory authorities of these findings and its decision to cease distribution and ongoing studies. Aida Habtezion, Pfizer's Chief Medical Officer, emphasized that patient safety is paramount and that this action is considered to be in the best interest of patients. She noted that SCD remains a serious and difficult-to-treat disease with limited therapeutic options.
The company advises patients to consult their physicians to discuss alternative treatment options while Pfizer continues to investigate the data. Pfizer stated it does not anticipate this withdrawal will impact its full-year 2024 financial guidance.