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Dupixent Approval Status

  • FDA approved: No
  • Brand name: Dupixent
  • Generic name: dupilumab
  • Company: Sanofi and Regeneron Pharmaceuticals, Inc.
  • Treatment for: Atopic Dermatitis

Dupixent (dupilumab) is an investigational human monoclonal antibody in development for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. Dupilumab inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be major driver in the pathogenesis of the disease.

Development Status and FDA Approval Process for Dupixent

DateArticle
Sep 26, 2016Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
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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