Press release
Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement
Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population Phase 3 trial showed more than twice
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population Phase 3 trial showed more than twice as many patients treated with Dupixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries. “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,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Dupixent has been used to treat hundreds of thousands of patients with moderate-to-severe atopic dermatitis around the world since its initial U.S. approval in 2017, and we are pleased that Dupixent is now the first biologic with data in the label supporting its use in this particularly challenging subset of the disease.” “Living with atopic dermatitis on your most essential body areas like the hands and feet can make daily activities including walking and writing incredibly burdensome even in the case where disease symptoms are mild elsewhere. Unfortunately, treating atopic dermatitis on the hands and feet has historically been difficult and there have been no Phase 3 trials evaluating a biologic in this population of patients,” said Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation at Sanofi. “Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-estab...