The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for dupilumab (Dupixent, Sanofi/Regeneron Pharmaceuticals) for the treatment of adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Dupilumab will be available as a 300-mg injectable solution. It is a recombinant human IgG4 monoclonal antibody that inhibits the signaling of interleukin-4 and interleukin-13.
In three clinical trials, dupilumab improved skin condition in patients with atopic dermatitis as measured by improved scores on the Investigator Global Assessment and Eczema Area and Severity Index-75 scales. It also relieved itching.
In March this year, the US Food and Drug Administration approved dupilumab for moderate to severe atopic dermatitis not adequately controlled with topical therapies or for use when those therapies are contraindicated.
Dupilumab should be prescribed by physicians experienced in treatment of atopic dermatitis.
The European public assessment report will publish the summary of product characteristics, which will include detailed recommendations for dupilumab use. The summary will be published in all official European Union languages after the European Commission grants marketing authorization.
Cite this: EU Panel Recommends Dupilumab (Dupixent) for Eczema - Medscape - Jul 21, 2017.