Oxbryta (voxelotor) was FDA-approved for sickle cell disease and then voluntarily withdrawn by Pfizer in September 2024 after a clinical trial showed patients taking the drug had higher rates of death, stroke, and vaso-occlusive crises compared to placebo. This is a very early-stage emerging tort with limited plaintiff filings.
The HOPE trial extension data revealed statistically significant increased mortality and vaso-occlusive crisis events in the voxelotor arm. The mechanism is under investigation. Pfizer/GBT are alleged to have known about safety signals and delayed withdrawal.
Pfizer recalled Oxbryta (voxelotor) in November 2023 following post-market data showing increased mortality risk in sickle cell patients. Litigation is in early stages. No MDL formed. State court filings beginning. First-mover advantage for plaintiff firms.