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Dupixent Approval History

Reviewed on Mar 28, 2017 by J.Stewart BPharm
  • FDA approved: Yes (First approved March 28th, 2017)
  • Brand name: Dupixent
  • Generic name: dupilumab
  • Dosage form: Injection
  • Company: Sanofi and Regeneron Pharmaceuticals, Inc.
  • Treatment for: Atopic Dermatitis

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis.

The FDA approval of Dupixent was based on the results of the LIBERTY AD Clinical Program which included three randomized Phase 3 pivotal trials of 2,119 adult patients with inadequately controlled atopic dermatitis. The SOLO 1 and SOLO 2 trials examined Dupixent as monotherapy, and the CHRONOS trial examined treatment with both Dupixent and topical corticosteroids. In all trials, Dupixent significantly improved measures of skin clearing, intensity, and severity of disease at 16 weeks compared to placebo.

Dupixent is self-administered via subcutaneous injection every other week after an initial loading dose. Common side effects include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.

Development History and FDA Approval Process for Dupixent

Mar 28, 2017Approval FDA Approves Dupixent (dupilumab) for Eczema
Mar  4, 2017Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent (dupilumab) in Moderate-to-Severe Atopic Dermatitis
Oct  1, 2016Sanofi and Regeneron Announce Positive Dupixent (dupilumab) Phase 3 Atopic Dermatitis Data Published in The New England Journal of Medicine
Sep 26, 2016Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
Jun  6, 2016Sanofi and Regeneron Announce that Dupilumab Used with Topical Corticosteroids (TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Trial in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients
Apr  1, 2016Sanofi and Regeneron Announce Positive Dupilumab Topline Results From Two Phase 3 Trials in Inadequately Controlled Moderate-To-Severe Atopic Dermatitis Patients
Feb  2, 2016Sanofi and Regeneron Announce Publication of Positive Phase 2 Dupilumab Data
May 18, 2015Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in Asthma
Nov 20, 2014Sanofi And Regeneron Announce That Dupilumab Has Received FDA Breakthrough Therapy Designation In Atopic Dermatitis
Nov 11, 2014Sanofi And Regeneron Announce Positive Results From Phase 2b Study of Dupilumab
Oct 20, 2014Sanofi And Regeneron Announce Start Of Phase 3 Study Of Dupilumab in Patients With Atopic Dermatitis
Sep 30, 2014Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps
Jul  9, 2014Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab for Atopic Dermatitis
May 21, 2013Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma
Mar  4, 2013Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis

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