(Reuters) -U.S. drugmaker Pfizer said on Wednesday it is withdrawing its sickle cell disease therapy Oxbryta in all markets where it is approved and discontinuing all studies and access programs related to the treatment.
The decision is based on the totality of clinical data, which now indicates that the benefit of Oxbryta no longer outweighs the risks associated with its use, Pfizer said.
The company added that the data for Oxbryta shows that there is an imbalance in vaso-occlusive crises, a complication of the disease and “fatal events” which require further assessment.
Pfizer said it will further review and investigate the available data and had notified regulatory authorities about its findings.
Pfizer had acquired the therapy, also known as voxelotor, as part of its $5.4 billion buyout of Global Blood Therapeutics in 2022. It reported revenues of $92 million from the therapy for the second quarter ended June 30.
Oxbryta was approved in the U.S. in 2019 for treatment of the inherited blood disorder in which red blood cells become sickle or crescent shaped.
The company said it does not anticipate that the withdrawal will impact its full-year 2024 financial outlook.
Shares of the drugmaker were trading marginally down at $28.84 in extended hours.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Mohammed Safi Shamsi)
