In September 2024, Pfizer voluntarily withdrew all lots of OXBRYTA for the treatment of SCD in all markets where it was approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanding access programs worldwide. The decision is based on the totality of clinical data, which now indicates that the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population. The data suggest an imbalance in vaso-occlusive crises and fatal events, which requires further assessment.
OXBRYTA, which received FDA accelerated approval in November 2019, was one of the treatments in question. Another such treatment, Novartis’...
