Sanofi: FDA priority review in bullous pemphigoid
(CercleFinance.com) - Sanofi announced today that the US FDA has granted priority review to the supplemental Biologics License Application (sBLA) for its Dupixent (dupilumab) product for the treatment of bullous pemphigoid in adults.
This priority review is granted on the basis of positive results from the pivotal study showing that Dupixent achieves significant improvements in terms of sustained remission of the disease, compared to placebo.
If approved, the application will be the first and only targeted drug in the US to treat this chronic, disabling and recurrent skin disease with underlying type 2 inflammation. The FDA's decision is expected on 20 June.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
This priority review is granted on the basis of positive results from the pivotal study showing that Dupixent achieves significant improvements in terms of sustained remission of the disease, compared to placebo.
If approved, the application will be the first and only targeted drug in the US to treat this chronic, disabling and recurrent skin disease with underlying type 2 inflammation. The FDA's decision is expected on 20 June.
Copyright (c) 2025 CercleFinance.com. All rights reserved.