Pfizer Pulls OXBRYTA® Treatment For Sickle Cell Globally

Pfizer Inc. (NYSE: PFE) has decided to pull all batches of OXBRYTA® (voxelotor), used for treating sickle cell disease (SCD), from every market where it is currently available. Additionally, the company is ceasing all ongoing voxelotor clinical trials and expanded access programs globally.

Pfizer's choice to withdraw OXBRYTA stems from a comprehensive review of clinical data, which now shows that the benefits of the drug may not surpass the risks for sickle cell patients. The data have revealed an increased incidence of vaso-occlusive crises and fatal events, prompting the need for further evaluation. Pfizer has informed regulatory agencies of these concerns and its decision to remove OXBRYTA from the market, halt distribution, and stop ongoing clinical studies while it continues to analyze the data and investigate the issues.

Head of Worldwide Medical and Safety & Chief Medical Officer at Pfizer, Aida Habtezion stated, “The safety and well-being of patients is of the utmost importance to Pfizer, and we believe this action is in the best interest of patients. Our primary concern is for patients who suffer from SCD, which remains a severe and difficult-to-treat disease with limited treatment options. We advise patients to contact their physicians to discuss alternative treatment while we continue to investigate the findings from our data review.”