Pfizer: voluntary withdrawal of all lots of voxelotor
(CercleFinance.com) - Pfizer has announced that it is voluntarily withdrawing all lots of OXBRYTA (voxelotor) for the treatment of sickle cell disease (SCD) in all markets where it is currently approved.
Pfizer is also terminating all active voxelotor clinical trials and expanded access programs worldwide.
Pfizer says that its decision is based on the body of clinical data which now indicates that the overall benefits of OXBRYTA no longer outweigh the risks in the approved sickle cell patient population. The data suggest an imbalance between vaso-occlusive crises and fatal events which require further evaluation.
Pfizer has informed the regulatory authorities of these results and of its decision to voluntarily withdraw OXBRYTA from the market and discontinue distribution and clinical studies while it further reviews the available data and investigates the results.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
Pfizer is also terminating all active voxelotor clinical trials and expanded access programs worldwide.
Pfizer says that its decision is based on the body of clinical data which now indicates that the overall benefits of OXBRYTA no longer outweigh the risks in the approved sickle cell patient population. The data suggest an imbalance between vaso-occlusive crises and fatal events which require further evaluation.
Pfizer has informed the regulatory authorities of these results and of its decision to voluntarily withdraw OXBRYTA from the market and discontinue distribution and clinical studies while it further reviews the available data and investigates the results.
Copyright (c) 2024 CercleFinance.com. All rights reserved.