Pfizer looking into data suggesting a potential link to sickle-cell complications and 'fatal events'.
Pfizer Inc. said late Wednesday it was withdrawing a sickle-cell drug from markets worldwide and discontinuing clinical trials of the treatment after it investigates data suggesting a potential link to sickle-cell complications and "fatal events."
"Pfizer's decision is based on the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle-cell patient population," the pharma giant said in a statement.
"The data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment." Vaso-occlusive crises are a relatively common complication of sickle-cell anemia.
Pfizer said it does not expect the voluntary action to impact its full-year 2024 financial guidance.
Pfizer has notified regulatory authorities about its decision to withdraw the treatment while it further reviews the available data and investigates the findings, it said.
"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," Pfizer Chief Medical Officer Aida Habtezion said.
The company advises patients to discuss alternative treatments with their doctor, as sickle-cell disease remains a serious and difficult-to-treat illness with limited treatment options.
The Food and Drug Administration granted accelerated approval for Oxbryta tablets in 2019 for adults and teens. In December 2021, the FDA expanded the approved the use for the treatment of children.