FDA announces recall of Pfizer's fast-tracked sickle cell drug
Pfizer is voluntarily pulling a sickle cell disease drug from the market worldwide, citing safety concerns. The recall, which is effective immediately, was announced by the U.S. Food and Drug Administration (FDA) on Thursday.
Oxbryta was fast tracked for approval by the FDA in 2019, driven by positive hemoglobin levels in sickle cell patients when compared to a placebo. Europe followed suit in 2022 based on the same evidence. Now, over concerns the drug could increase the risk of death, Pfizer is pulling it from pharmacy shelves as a precaution.
“In post-marketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease receiving Oxbryta compared to placebo,” the statement from the FDA said. “There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these post-marketing studies.”
Pfizer confirmed the decision to recall the drug is only because the benefits may no longer outweigh the risks. Research on Oxbryta has been ongoing, and more studies are needed before it can be safely prescribed for sickle cell disease.
The drug was prescribed to both adults and children alike.
“Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies. Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk,” the FDA added.
The recall is a huge blow to Pfizer, which heavily invested in sickle cell therapies on the assumption Oxbryta was a world-class treatment. The drug spurred the purchase of Global Blood Therapeutics in 2022—a move Pfizer made to expand its portfolio of treatments for sickle cell and other blood diseases. The acquisition closed for $5.4 billion.
Pfizer said it has notified legal authorities globally about the moratorium on Oxbryta prescriptions. Remaining stocks are to be destroyed.
The FDA is asking providers and patients to submit feedback in regards to side effects or deaths linked to usage of the drug. The FDA MedWatch form to report adverse events can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.