BioPharma Dive September 26, 2024
The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S. in 2019.
Dive Brief:
- Pfizer is pulling the sickle cell disease drug Oxbryta off the market and ending clinical trials of the medicine around the world due to safety concerns.
- Clinical data “now indicates that the overall benefit of Oxbryta no longer outweighs the risk,” Pfizer said Wednesday. The company said data show an imbalance of deaths and vaso-occlusive crises, the excruciating episodes of pain that patients with sickle cell disease experience. The company said it notified regulatory authorities of the results.
- Pfizer’s decision came a day before European regulators met to review Oxbryta’ safety. The European Medicines Agency...
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