EU regulator accepts Sanofi/Regeneron's Dupixent product for review

[December 08, 2016]  PARIS (Reuters) - The European Medicines Agency (EMA), the European Union's health regulator, has accepted for review the Dupixent product being developed by drugmakers Sanofi and Regeneron, the companies said on Thursday.

Dupixent is aimed at adults with eczema or moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy.

If cleared by regulators, Dupixent would be the first approved systemic treatment for eczema, which in severe cases produces infection-prone rashes and a constant itch as bad as poison ivy. Some analysts expect Dupixent to cost up to $30,000 a year and to capture eventual annual sales of more than $5 billion.

A biologics license application (BLA) for Dupixent was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) in September.

As per the U.S. Prescription Drug User Fee Act (PDUFA), the target FDA action date is March 29. The EMA and FDA have conditionally accepted Dupixent as the trade name for dupilumab.

Eczema affects an estimated two percent of U.S. adults, and as many as 10 percent to 20 percent of children - the majority of cases being of mild to moderate severity.

Sanofi shares, which closed down 0.6 percent at 75.10 euros on Wednesday, are down by around 4.5 percent so far in 2016.

Regeneron shares closed down 1.9 percent on Wednesday, with Regeneron's stock down by around 33 percent so far this year.

(Reporting by Sudip Kar-Gupta; Editing by Amrutha Gayathri)

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