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Key Takeaways
- Pfizer is withdrawing all of its sickle cell disease drug, Oxbryta, worldwide because of safety concerns.
- The drug maker said the benefits of Oxbryta no longer outweigh the risks.
- The company’s data indicated patients could suffer from severe pain and even death.
Pfizer (PFE) shares declined Thursday after the drug maker recalled all lots of its sickle cell disease medicine worldwide because of concerns it could lead to severe pain and possibly death in patients.
The company announced it was voluntarily recalling Oxbryta and ending all active clinical trials and expanded access programs for its key ingredient, voxelotor.
Oxbryta Benefit ‘No Longer Outweighs the Risk’
Pfizer explained that the decision was made “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.”
The company said the data suggest the treatment can cause “an imbalance in vaso-occlusive crises and fatal events which require further assessment.” Pfizer noted it has advised regulators about the findings and recall.
Aida Habtezion, Chief Medical Officer and Head of Worldwide Medical and Safety at Pfizer, advised those taking Oxbryta to contact their doctors to discuss alternative medicines while the company continues to investigate.
Shares of Pfizer, which slipped less than 1% an hour after the opening bell Thursday, are little changed this year.