Sanofi: Dupixent gets extended approval for paediatric use
(CercleFinance.com) - Sanofi has said that the European Commission has extended the marketing authorisation of Dupixent in the European Union to children aged six to 11 years with severe atopic dermatitis requiring systemic treatment.
The healthcare group points out that this decision, which is primarily based on the results of a pivotal phase III trial, makes Dupixent the only systemic drug approved in the EU for the treatment of this category of patients.
Dupixent, in combination with topical corticosteroids, reduced itching in four times as many children as treatment with topical corticosteroids alone, with three times as many children having experienced complete or near-complete healing of the skin.
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The healthcare group points out that this decision, which is primarily based on the results of a pivotal phase III trial, makes Dupixent the only systemic drug approved in the EU for the treatment of this category of patients.
Dupixent, in combination with topical corticosteroids, reduced itching in four times as many children as treatment with topical corticosteroids alone, with three times as many children having experienced complete or near-complete healing of the skin.
Copyright (c) 2020 CercleFinance.com. All rights reserved.