Sanofi: positive CHMP opinion in atopic dermatitis
(CercleFinance.com) - Sanofi has said that that the Committee for Medicinal Products for Human Use (CHMP) has recommended the extension of Dupixent's marketing authorisation to the treatment of moderate-to-severe atopic dermatitis in teenagers (12 to 17 year olds) who need systemic treatment.
If the indication is approved, Dupixent will be the first biologic drug approved in the European Union for the treatment of this category of patients. The European Commission's final decision is expected in the next few months.
The CHMP's favourable opinion is based on clinical data from the LIBERTY AD program, including the pivotal Phase III clinical trial and its open-ended extension that assessed the efficacy and safety of Dupixent in teenagers.
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If the indication is approved, Dupixent will be the first biologic drug approved in the European Union for the treatment of this category of patients. The European Commission's final decision is expected in the next few months.
The CHMP's favourable opinion is based on clinical data from the LIBERTY AD program, including the pivotal Phase III clinical trial and its open-ended extension that assessed the efficacy and safety of Dupixent in teenagers.
Copyright (c) 2019 CercleFinance.com. All rights reserved.