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# Regeneron Eczema Drug Approved by FDA
- URL: https://www.fdaweb.com/regeneron-eczema-drug-approved-by-fda/
- Published: 2017-03-28T12:00:00.000Z
- Updated: 2026-09-14T22:14:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138312

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 ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm?ref=fdaweb.com)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.