Pfizer Confirms Oxbryta® Will Not Return to the U.S. Market: What the Sickle Cell Community Needs to Know
The Jasmine Sickle Cell Warriors Foundation remains committed to keeping our community informed about important developments that affect individuals and families living with sickle cell disease.
Pfizer has announced that Oxbryta® (voxelotor) will not return to the U.S. market following extensive discussions with the U.S. Food and Drug Administration (FDA).
Over the past two years, Pfizer conducted a comprehensive review of data from clinical trials, real-world patient registries, and post-marketing safety and effectiveness studies. The company submitted these findings to the FDA and continued discussions in hopes of identifying a path to make the medication available again.
After reviewing the available evidence, the FDA determined that there is no viable path for Oxbryta to return to the United States.
This news is understandably disappointing for many sickle cell warriors, caregivers, healthcare providers, and advocates. Oxbryta represented an important treatment option for many individuals living with sickle cell disease, and its absence highlights the continued need for safe and effective therapies.
Despite this decision, Pfizer has reaffirmed its commitment to the sickle cell community. The company announced that it will continue investing in sickle cell research, including the ongoing development of osivelotor, while working toward future treatment options for people living with the disease.
Pfizer also stated that it will continue sharing research findings from the Oxbryta program as they become available. This includes publications in medical journals as well as plain-language summaries designed to help patients, caregivers, and community organizations better understand the research. The knowledge gained from the Oxbryta program is expected to contribute to future advancements in sickle cell treatment and innovation.
At the Jasmine Sickle Cell Warriors Foundation, we know that updates like these can be difficult to hear. We encourage our community to continue speaking with their healthcare providers about available treatment options and to stay informed as new therapies continue to be researched and developed.
We remain hopeful that continued scientific innovation will lead to additional treatments that improve the quality of life for sickle cell warriors around the world.
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To read Pfizer's official public statement regarding Oxbryta and learn more about this announcement, visit Oxbryta.com, where visitors will be directed to Pfizer's latest information and updates.
As always, the Jasmine Sickle Cell Warriors Foundation will continue sharing important news, advocacy updates, research developments, and resources to help empower and strengthen the sickle cell community.
