FDA approves new eczema drug Dupixent

The US Food and Drug Administration has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).

Dupixent, from French pharma major Sanofi (Euronext: SAN) and US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN), is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

Analysts are forecasting peak sales of Dupixent as high as $5 billion per year. The European regulatory filing for Dupixent, which was endorsed in late 2016, is currently being processed by the European Medicines Agency, with a decision expected this year.