Another FDA approval for Dupixent

12 March 2019
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The US Food and Drug Administration has approved another indication for Dupixent (dupilumab), this time for adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Developed by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN), Dupixent can be used with or without topical corticosteroids. The drug generated sales of 783 million euros ($879 million) for Sanofi last year.

"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. Today's approval expands the use of Dupixent in the US to include both adults and adolescents with atopic dermatitis or moderate-to-severe asthma," said Dr George Yancopoulos, president and chief scientific officer at Regeneron.

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