Regeneron Eczema Drug Approved by FDA

FDA has approved a Regeneron Pharmaceuticals NDA for Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema. The drug is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable, an agency release says. Injected under the skin, Dupixent works by binding to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)] that causes inflammation, which then inhibits the inflammatory response that plays a role in the development of atopic dermatitis, FDA says.

Approval was based on data from three placebo-controlled clinical trials with a total of 2,119 adult participants. “Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment,” the agency says.