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Dupixent FDA Asthma Review Bolsters Sanofi And Regeneron

 
• By Kevin Grogan

Already approved for atopic dermatitis, the partners have got a PDUFA date of Oct. 20 which could expand the label on their interleukin-4 and -13 inhibitor to include asthma.

Exercise
Looking to expand Dupixent • Source: Shutterstock

Sanofi and Regeneron Pharmaceuticals Inc.'s hopes to turn their eczema drug Dupixent (dupilumab) from a big-seller into a mega-blockbuster have been raised by the news that the FDA is reviewing the therapy as a treatment for asthma.

Dupixent, which was approved in March 2017 by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical therapies or for whom the latter are not advisable, had sales of €118m in the fourth quarter, almost all of which came from the US

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