FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sanofi and Regeneron’s Dupixent Gains Priority Review From FDA

Nov. 15, 2018
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The FDA granted priority review status for Sanofi and Regeneron’s Dupixent (dupilumab), a monoclonal antibody treatment for moderate-to-severe eczema.

The drugmakers are looking for approval to market Dupixent to patients aged 12 to 17 who have not seen adequate results from topical treatments or cannot use them for medical reasons.

Dupixent was previously shot down in April by the UK’s National Institute for Health Care and Excellence over concerns about the drug’s cost-effectiveness, despite finding it innovative for patients in need of new treatments.

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