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Dupilumab Receives ‘Breakthrough Therapy’ Designation for Atopic Dermatitis
The FDA has granted a “breakthrough therapy” designation to dupilumab (Regeneron Pharmaceuticals/Sanofi) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. The designation is based on positive results from phase I and II clinical trials.
“Breakthrough therapy” status was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. A “breakthrough therapy” drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint compared with available therapies, or compared with placebo if there is no available therapy.
A phase III worldwide clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing.
Dupilumab, an investigational fully-human monoclonal antibody, is directed against the shared interleukin (IL)-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of the Th2 (type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation.
Dupilumab is being developed for the treatment of atopic dermatitis, asthma, and chronic sinusitis with nasal polyposis. It is an investigational agent under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Moderate-to-severe atopic dermatitis, a serious form of eczema, is a chronic inflammatory disease characterized by an allergic response driven by Th2 cells. The moderate-to-severe forms of the disease are characterized by pronounced pruritus, cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification (skin thickening), with periods of lesion exacerbation. Intense itching, scratching, and skin damage can lead to secondary infections. Atopic dermatitis is often associated with other inflammatory disorders, such as asthma.
Source: Regeneron Corporation; November 20, 2014.