Pfizer Withdraws Oxbryta, But Overall Market Impact May Be Limited

EU Regulators Recommend Suspending Approval

The withdrawal amid concerns about the risk-benefit ratio reduces treatment options for sickle cell disease, but it is not expected to have much effect on the SCD market, including the gene therapies.

• Source: Shutterstock

Less than a year ago, Pfizer Inc. was securing reimbursement in the UK for its sickle cell disease (SCD) drug, Oxbryta (voxelitor), while hematologists were debating how the increasing number of options for SCD – including Oxbryta – would fit into the treatment paradigm. Now, the URL for the drug’s website redirects to Pfizer’s announcement that it is pulling the drug from the market, while European regulators are recommending suspension of its marketing authorization there.

The New York-based drug maker said 25 September after the stock market closed that it was voluntarily withdrawing all lots of Oxbryta from markets around the world and stopping all clinical trials of the drug after the emergence of clinical data indicating that its overall benefit did not outweigh its

Key Takeaways
  • Pfizer withdrew all lots of Oxbryta worldwide and closed clinical trials for the drug amid concerns about the drug’s safety, including fatal adverse events.

  • The European Medicines Agency’s CHMP also recommended suspending the drug’s marketing authorization

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