Regeneron Pharmaceuticals Inc REGN:NASDAQ

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European Regulator Recommends Approval of Regeneron Pharmaceuticals' Atopic Dermatitis Drug in Adolescents

7:43AM ET 6/28/2019 MT Newswires
Regeneron Pharmaceuticals (REGN) and Sanofi said pre-market Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Dupixent and recommended to extend its approval in the European Union to include adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

If approved, Dupixent would be the first biologic medicine approved in the region to treat these patients. The European Commission's final decision on the dupixent application is expected in the coming months, Regeneron said.

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