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EMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets

The CHMP is holding an extraordinary meeting to discuss the emerging data for the sickle cell disease drug

 
• By Neena Brizmohun

The company’s decision to withdraw the drug was 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.”

Oxbryta was the first medicine approved that directly inhibits sickle hemoglobin polymerization, the root cause of SCD • Source: Shutterstock

The European Medicines Agency is holding a meeting today to discuss the emerging clinical data and deaths that have caused Pfizer to voluntarily withdrawing its sickle cell disease (SCD) treatment, Oxbryta (voxelotor), from the 35 countries in which it is approved for marketing.

The company said it was pulling the drug at this time, discontinuing distribution and clinical studies while further reviewing the...

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