Pfizer Inc. announced it will withdraw its sickle cell disease treatment, Oxbryta, from the market after clinical trial data showed an increased risk of patient deaths and complications.
The company stated that the overall benefit of Oxbryta, a first-in-class therapy approved to address the underlying cause of sickle cell disease, “no longer outweighs the risk.”
The decision comes after the discovery of an imbalance in the incidence of vaso-occlusive crises—painful episodes common in sickle cell disease patients—and fatal events. As a result, Pfizer will also discontinue all clinical trials involving Oxbryta as it continues to assess the situation.
However, Pfizer clarified that this decision will not affect its ongoing sickle cell drug candidates, including inclacumab and osivelotor (GBT-601). A spokesperson confirmed that the company remains committed to advancing its pipeline, and updates on its experimental drugs will be provided as they become available.
Oxbryta’s withdrawal comes just before the European Medicines Agency was set to review the drug after higher-than-expected deaths were reported in two clinical trials. The therapy, originally developed by Global Blood Therapeutics, was acquired by Pfizer in 2022 for $5.4 billion.
Despite the setback with Oxbryta, Pfizer CEO Albert Bourla has expressed optimism about GBT-601, which showed promise in a mid-stage study last year. He referred to it as a potential improvement over Oxbryta, further emphasizing the company’s continued efforts in sickle cell treatment development.
Pfizer has notified regulatory authorities of its decision and advised patients currently on Oxbryta to consult their doctors for alternative treatments. The company maintains that this voluntary action will not impact its financial outlook for 2024.
“The safety and well-being of patients is our top priority… We believe this action is in the best interest of patients,” said Pfizer Chief Medical Officer Aida Habtezion.
With input from Bloomberg and Market Watch.
