Sanofi, Regeneron's Dupixent gains expanded approval in US for certain adolescents with atopic dermatitis

Sanofi and Regeneron Pharmaceuticals on Monday announced that the FDA has expanded approval of Dupixent (dupilumab) to include use in adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regeneron chief scientific officer George Yancopoulos remarked "for the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash."  

Approval of the drug for the expanded indication was backed by efficacy and safety data from a Phase III study of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis. Results from the study, which were unveiled last September, showed that the therapy was linked to an approximately 66-percent improvement in the Eczema Area and Severity Index versus baseline, compared with 24 percent for placebo.  Further, the companies said that 24 percent of patients who received Dupixent achieved clear or almost clear skin compared to 2 percent with placebo, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, which was the primary endpoint of the trial.

The FDA previously granted priority review and breakthrough therapy designation to Dupixent for use in adolescents with moderate-to-severe atopic dermatitis. The IL-4 and IL-13 inhibitor was initially authorised by the FDA in 2017 for the treatment of certain adults with moderate-to-severe atopic dermatitis, while its indication was later expanded to include patients aged 12 and older with moderate-to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. 

Sales of Dupixent for the quarter ended December 31 more than doubled to 280 million euros ($315 million) compared to the fourth quarter of 2017. Meanwhile, Sanofi and Regeneron announced earlier this month that the treatment was accepted for priority review by the FDA for use as an add-on maintenance therapy for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps.  

For related analysis on the therapy, see ViewPoints: Two Dupixent rivals look like pretenders, but readout for key contender on horizon.

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