Pfizer Recalls Oxbryta Amid Rising Risk of Fatal Complications, 8 Deaths Shock the World, and $538 Million Acquisition in 2023

U.S. pharmaceutical giant Pfizer announced on Wednesday that it was withdrawing its sickle cell disease treatment Oxbryta (also known as Voxelotor) from all approved markets because of the risk of serious complications and death.

Oxbryta was originally a product of Global Blood Therapeutics, and Pfizer acquired Oxbryta in 2022 for up to $5.4 billion. According to statistics, the treatment contributed $328 million to Pfizer's revenue in the full year 2023.

However, based on the current review of clinical data, Pfizer believes that the benefits of Oxbryta no longer outweigh its potential risks and has decided to discontinue all research and market access programs related to Oxbryta. The company pointed out that the data reflect a significant imbalance in the incidence of vascular occlusion crisis, a potentially fatal complication of the disease, which needs further evaluation and discussion. An occlusive crisis usually occurs when blood flow is blocked, tissue is starved of oxygen and inflammation is triggered.

The decision comes as the European Medicines Agency's Committee for Medicinal Products for Human Use plans to hold a special meeting on Thursday to consider Pfizer's drug. Notably, in a study involving 236 participants, eight of those treated with Oxbryta died, compared to just two in the placebo group.

In response to this situation, Pfizer said that it will continue to analyze the existing data in depth and has informed the relevant regulatory authorities of the findings in a timely manner. In the meantime, the company recommends that all patients who are being treated with Oxbryta speak with a healthcare professional as soon as possible to explore possible alternative treatment options.

Oxbryta was originally developed to treat a genetic blood disorder that causes red blood cells to form abnormally, which increases the risk of stroke, organ damage and premature death. Nevertheless, Pfizer stressed that the delisting decision is not expected to have a significant impact on its overall financial performance in 2024.