Sanofi: FDA to review license application
(CercleFinance.com) - The FDA has agreed to review the application for an indication for the treatment of chronic spontaneous urticaria in adults and adolescents 12 years of age and older.
The US FDA has agreed to review the supplemental Biologics License Application for Dupixent (dupilumab). The FDA is expected to make its decision on 22 October 2023.
Chronic spontaneous urticaria is an inflammatory skin disease caused in part by type 2 inflammation. It is seen in a sudden appearance of disabling hives and swelling of the skin.
This swelling, or angioedema, most often occurs on the face, hands and feet, but can also spread to the throat and upper respiratory tract.
The supplemental license application is based on data from two Phase III trials (LIBERTY-CUPID A and B studies), which evaluated Dupixent in two different patient populations with uncontrolled spontaneous chronic urticaria.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
The US FDA has agreed to review the supplemental Biologics License Application for Dupixent (dupilumab). The FDA is expected to make its decision on 22 October 2023.
Chronic spontaneous urticaria is an inflammatory skin disease caused in part by type 2 inflammation. It is seen in a sudden appearance of disabling hives and swelling of the skin.
This swelling, or angioedema, most often occurs on the face, hands and feet, but can also spread to the throat and upper respiratory tract.
The supplemental license application is based on data from two Phase III trials (LIBERTY-CUPID A and B studies), which evaluated Dupixent in two different patient populations with uncontrolled spontaneous chronic urticaria.
Copyright (c) 2023 CercleFinance.com. All rights reserved.