Pfizer Withdraws Sickle Cell Drug Oxbryta from Market
Clinical data suggests an imbalance in vaso-occlusive crises and fatal events that require further assessment, and the company said it will provide updates in the future.
Pfizer is withdrawing all lots of Oxbryta (voxelotor) and discontinuing all clinical trials of the drug, which is used to treat patients with sickle cell disease. Pfizer is advising patients to contact their physicians to discuss alternative treatments.
Pfizer's decision is based on the totality of clinical data, which “suggest an imbalance in vaso-occlusive crises and fatal events that require further assessment,” the company said in its announcement.
Pfizer has notified regulatory authorities about these findings and its decision to discontinue distribution and clinical studies while it reviews available data. A company spokesperson said Pfizer will share updates on presentation or publication timing in the future.
The product’s website is redirecting to the Pfizer’s withdrawal notice.
Pfizer acquired Oxbryta through its acquisition of Global Blood Therapeutics in October 2022 for about $5.4 billion. In 2023, Oxbryta generated sales of $328 million.
The FDA granted accelerated approval in 2019 for Oxbryta to treat sickle cell disease in adults and children ages 12 years and older. In December 2021, the FDA expanded the approval to patients 4 years of age and older.
