Another step closer to a new atopic dermatitis treatment
On Monday, June 6, 2016 the pharmaceutical companies Regeneron and Sanofi Genzyme, reported positive results for the Phase 3 the clinical trial of the new biologic drug, dupilumab, when used in conjunction with a topical corticosteroid by adults to treat moderate-to-severe atopic dermatitis (AD).
As defined by the National Institutes of Health, a Phase 3 clinical trial is one when “the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.”
This is the third favorable Phase 3 trial for dupilumab. Results included significant improvement in AD severity, skin clearing, itch, and patient quality of life. The first and second Phase 3 results reported this past April also showed significantly cleared skin, reduced itch, and improved patient quality of life in adults with AD when dupilumab was used alone (without a topical corticosteroid).
Dupilumab is an injectable, biologic medication, which is a class of medicines made from proteins that are derived from human DNA and can be used to treat a variety of conditions including rheumatoid arthritis, psoriasis, and cancer.
The U.S. Food and Drug Administration (FDA) granted dupilumab Breakthrough Therapy designation in AD in November 2014. The FDA defines a breakthrough therapy as a drug:
- intended alone or in combination with one or more other drugs to treat serious or life threatening disease or condition and
- preliminary clinical evidence indicates that the drug may demonstrate substantial improvements over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Because dupilumab is designated as a breakthrough AD therapy, it is expected to come to market as early as 2017.
This is an unprecedented and hopeful time for all people living with eczema. In addition to dupilumab, there are dozens of new therapies to treat eczema and AD in development that have the potential to reduce symptoms and improve quality of life.