On Wednesday (September 25), US drugmaker Pfizer announced it would withdraw its sickle cell disease treatment, Oxbryta, from all approved markets.
The decision comes due to serious concerns regarding painful complications and the potential for deaths related to the drug. This marks a significant turn for a treatment that was expected to help many people suffering from this genetic blood disorder.
Pfizer's Oxbryta Faces Safety Concerns
Pfizer purchased Oxbryta, also known as voxelotor, as part of a $5.4 billion buyout of Global Blood Therapeutics in 2022. Since then, Oxbryta generated an impressive $328 million in revenue for Pfizer in 2023.
However, despite its financial success, the safety of the drug has become a big issue. Pfizer announced it would stop all studies and access programs related to Oxbryta after reviewing clinical data that shows the risks now outweigh the benefits of using the medication.
The data revealed alarming findings about vaso-occlusive crises, a painful complication that can happen in people with sickle cell disease when blood flow is blocked. This blockage can lead to a lack of oxygen in tissues, causing severe pain and inflammation.
Pfizer's analysis showed that there were eight fatalities among the 236 participants in a recent study taking Oxbryta, compared to just two deaths in the placebo group.
This troubling information led to the company's decision to withdraw the drug from the market and conduct a more thorough analysis of the available data.
According to Reuters, the withdrawal decision comes just ahead of a special meeting set for Thursday. The European health regulator's Committee for Medicinal Products for Human Use is expected to evaluate the situation regarding Oxbryta.
Pfizer has already informed regulatory authorities about its findings, showing a commitment to being transparent and ensuring patient safety.
Oxbryta has been an important treatment for managing sickle cell disease, a genetic blood condition that causes red blood cells to change shape into sickles or crescents.
This can lead to serious health issues, including strokes, organ damage, and even early death. The US Food and Drug Administration (FDA) granted accelerated approval for Oxbryta in 2019. Since then, the drug has also received approvals in Europe, the United Kingdom, and the United Arab Emirates.
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Pfizer Remains Confident in Financial Outlook
Despite the withdrawal, Pfizer does not expect this decision to significantly impact its financial outlook for 2024. The company emphasized that it will continue to monitor the situation and evaluate the data associated with Oxbryta.
Aida Habtezion, Pfizer's Chief Medical Officer, reassured patients and healthcare providers that safety remains the company's top priority. She encouraged patients currently on Oxbryta to talk to their doctors to explore alternative treatment options while they continue to investigate the findings.
Sickle cell disease affects about 100,000 people in the United States, with a large majority being non-Hispanic Black or African American, according to the Centers for Disease Control and Prevention. This genetic disorder has long been a challenge for patients and healthcare providers alike, as there are limited treatment options available.
While Pfizer initially sought to create its own treatment for sickle cell disease, those efforts were unsuccessful, leading to the acquisition of Global Blood Therapeutics and the eventual approval of Oxbryta, according to The Wall Street Journal.
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