The U.S. Food and Drug Administration (FDA) on 28 March 2017 approved Dupixent injection to treat adults with moderate-to-severe eczema (atopic dermatitis).
Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable.
The injection will have an initial list price of USD 37000 per year, as per Sanofi SA and Regeneron Pharmaceuticals, which developed the drug.
• Dupixent is administered as an injection under the skin.
• The injection’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)], that causes inflammation.
• By binding to the protein, the drug is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis.
• The safety and efficacy of the injection were established in three placebo-controlled clinical trials with a total of 2119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication.
About atopic dermatitis
• Atopic dermatitis is a chronic inflammatory skin disease.
• It is the most common of the many types of eczema.
• Its cause is a combination of genetic, immune and environmental factors.
• In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy.
What: Approved by FDA
When: 28 March 2017