Sanofi and Regeneron have announced that their atopic dermatitis therapy Dupixient has been recommended for European regulatory approval.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the marketing authorisation of Dupixent as a treatment for adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
“Sanofi and Regeneron's Dupixent has been recommended in Europe for approval as a treatment for moderate to severe atopic dermatitis.“
This human monoclonal antibody is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation the characterises atopic dermatitis.
If approved, Dupixent will become the first investigational targeted biologic approved for this condition in Europe, and will come in a prefilled syringe for self-administration as a subcutaneous injection every other week after an initial loading dose.
The CHMP opinion is based on studies from the global LIBERTY study programme, which incorporated data from nearly 3,000 adult patients.
Atopic dermatitis is a form of eczema that causes itchy and debilitating rashes. People with the condition often experience a high level of disrupted sleep, increased anxiety and depression symptoms.
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