Sanofi: FDA grants priority review for dupixent
(CercleFinance.com) - Sanofi announces that the Food and Drug Administration (FDA) of the United States has given priority review to the application for a supplementary organic product licence (additional Biologics License Application) concerning dupixent (dupilumab).
This request concerns the treatment of moderate-to-severe atopic dermatitis in teenagers from 12 to 17 years of age who are inadequately controlled by topical treatments or for whom topical treatments are not recommended medically.
This is based on data from a pivotal phase III clinical trial presented at the congress of the European Academy of dermatology and venerology in September 2018. The FDA is due to give its decision on 11 March 2019.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
This request concerns the treatment of moderate-to-severe atopic dermatitis in teenagers from 12 to 17 years of age who are inadequately controlled by topical treatments or for whom topical treatments are not recommended medically.
This is based on data from a pivotal phase III clinical trial presented at the congress of the European Academy of dermatology and venerology in September 2018. The FDA is due to give its decision on 11 March 2019.
Copyright (c) 2018 CercleFinance.com. All rights reserved.