FDA

FDA offers quick thumbs up to expand Dupixent’s atopic dermatitis label as Regeneron/Sanofi plot blockbuster moves

Sanofi and Regeneron have racked up another approval for their blockbuster hopeful Dupixent as the FDA comes through following a priority review.

The IL-4/IL-13 inhibitor, which generated $882 million (€783 million) in worldwide sales in 2018, can now extend its reach to adolescents with moderate to severe atopic dermatitis.

George Yancopoulos

“For the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash,” said George Yancopoulos, Regeneron’s $REGN  president and CSO, in a statement.

As Dupixent targets a key pathway in type 2 inflammation, the two partners are still busy teasing its effects on other such diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, with some recent Phase III sweeps to boast.

John Reed

For the atopic dermatitis indication, Dupixent was shown to improve skin lesions, reduce itching, and help clear the skin of adolescent patients, Sanofi $SNY CMO John Reed added.

Key data points from that Phase III trial include an average improvement from baseline in the Eczema Area and Severity Index of 66% (versus 24% for placebo); 24% of patients achieving clear or almost clear skin (versus 2% with placebo); itch reduction in 37% of patients (versus 5% with placebo) and a predefined overall disease improvement in 42% of patients (versus 8% with placebo).

Dupixent has inspired peak sales estimates of $5 billion, while Geoffrey Porges of Leerink predicts its 2019 sales can reach $1.75 billion — with peak sales stretching past the $7 billion mark encompassing asthma and now an expanded patient population for eczema.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,300+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->