Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi jointly announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Dupixent's (dupilumab) approval in the EU for adolescents with moderate-to-sever atopic dermatitis.
If approved in the EU, Dupixent would be the first biologic medicine approved in the EU to treat patients 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. A final decision on the Dupixent application by the European Commission is expected in the coming months, revealed the partnership.
According to the companies, Dupixent is a fully-human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two proteins that play a central role in type 2 inflammation.
The partnership added that the positive CHMP opinion is based on clinical data from the LIBERTY AD programme, including a pivotal Phase 3 trial and an open-label extension trial evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis. The clinical trials have shown that inhibiting IL-4 and IL-13 helps address the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease. In its moderate-to-severe form it is characterised by rashes that can potentially cover much of the body and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing.
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