Pfizer Withdraws Sickle Cell Disease Treatment Oxbryta Globally Due to Safety Concerns

Global Withdrawal:
Pfizer has voluntarily withdrawn all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease from all markets where it is approved due to safety concerns.

Safety Concerns:
Clinical data indicate an imbalance in vaso-occlusive crises and fatal events, suggesting that the overall benefit of Oxbryta no longer outweighs the risk in the approved patient population.

Clinical Trials Ended:
Pfizer is discontinuing all active voxelotor clinical trials and expanded access programs worldwide.

Regulatory Notification:
Pfizer has notified regulatory authorities about these findings and its decision to withdraw Oxbryta from the market.

Alternative Treatments:
Patients currently taking Oxbryta are advised to contact their physicians to discuss alternative treatment options.

Background:
Oxbryta was first approved in the U.S. in 2019 and has been approved in over 35 countries globally for the treatment of hemolytic anemia due to sickle cell disease.

Future Developments:
Pfizer continues to work on other treatments for sickle cell disease, including two experimental medicines, inclacumab and osivelotor, which are in Phase 3 trials.