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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Sanofi and Regeneron Pharmaceuticals' dupilumab to treat adults with moderate-to-severe atopic dermatitis (AD).
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Dupilumab is indicated for AD patients who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
It is an investigational therapy that blocks IL-4 and IL-13, two cytokines required for the Th2 immune response.
The FDA breakthrough therapy designation is based on previously reported positive results from Phase I and II clinical trials.
National Eczema Association chief executive officer Julie Block said: "Moderate to severe atopic dermatitis is a debilitating, life-altering disease with very limited treatment options.
"Many patients suffer for years with widespread inflamed skin, debilitating itch, sleep disturbances and other challenges."
Currently, the companies are carrying out a Phase III clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis.
Dupilumab was developed using Regeneron’s VelocImmune technology and is being jointly developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyposis.