Dupixent receives FDA label update for atopic dermatitis on hands, feet

Key takeaways:

• The updated label shows safety and efficacy in treating moderate to severe atopic dermatitis of the hands or feet in patients aged 12 years and older.
• The label will be updated in the U.S. and European Union.

Dupixent for atopic dermatitis has received a label update from the FDA adding phase 3 efficacy and safety data, Regeneron and Sanofi announced in a press release.

The updated data for Dupixent (dupilumab, Regeneron/Sanofi) include results that demonstrate safety and efficacy for the treatment of patients aged 12 years and older with atopic dermatitis with uncontrolled moderate to severe involvement of the hand and/or foot.

The phase 3 LIBERTY-AD-HAFT trial, from which the data are pulled, is the first and only trial that evaluated a biologic in this indication. In addition to these data being added to the Dupixent label in the U.S., it will also be added to the European Union label.

“We rely heavily on our hands and feet throughout the day, making atopic dermatitis particularly disruptive for patients who experience constant itch and painful cracking and bleeding skin lesions on these critical areas of the body,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron and a principal inventor of Dupixent, said in the release.

In LIBERTY-AD-HAFT, 67 patients received Dupixent every 2 weeks — with adults taking 300 mg and adolescents taking 200 mg or 300 mg based on body weight — and 66 patients received placebo.

After 16 weeks of treatment, 40% of Dupixent-treated patients achieved the primary endpoint of clear or almost clear skin on their hands and feet vs. 17% of placebo-treated patients. Also, 52% saw a clinically meaningful reduction of itch on their hands and feet, whereas only 14% from the placebo group achieved this key secondary endpoint.