Pfizer has announced the withdrawal of all lots of Oxbryta, its drug for sickle cell disease, amid concerns about increased complications and fatal events.
The decision, effective immediately in all approved markets, comes after new clinical data indicated that the risks now outweigh benefits for patients, according to a Sept. 26 press release from the company. The data suggested an imbalance in vaso-occlusive crises and fatal events, requiring further assessment.
In addition to withdrawing the drug from the market, Pfizer is halting all active clinical trials and expanded access programs. The company has also notified regulatory authorities and said they plan to prioritize patient safety during the review process.
Aida Habtezion, MD, CMO at Pfizer, urged patients to consult their healthcare providers for alternative treatments.