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
|Sep 26, 2016||Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA|
|Apr 1, 2016||Sanofi and Regeneron Announce Positive Dupilumab Topline Results From Two Phase 3 Trials in Inadequately Controlled Moderate-To-Severe Atopic Dermatitis Patients|
|Feb 2, 2016||Sanofi and Regeneron Announce Publication of Positive Phase 2 Dupilumab Data|
|May 18, 2015||Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in Asthma|
|Nov 20, 2014||Sanofi And Regeneron Announce That Dupilumab Has Received FDA Breakthrough Therapy Designation In Atopic Dermatitis|
|Nov 11, 2014||Sanofi And Regeneron Announce Positive Results From Phase 2b Study of Dupilumab|
|Oct 20, 2014||Sanofi And Regeneron Announce Start Of Phase 3 Study Of Dupilumab in Patients With Atopic Dermatitis|
|Sep 30, 2014||Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps|
|Jul 9, 2014||Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab for Atopic Dermatitis|
|May 21, 2013||Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma|
|Mar 4, 2013||Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis|
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