Regeneron Pharmaceuticals and Sanofi’s dupilumab has received breakthrough therapy designation from US Food and Drug Administration (FDA) to treat adults with moderate-to-severe atopic dermatitis (AD).
The designation allows use of the drug for the treatment of patients with AD, who are not adequately controlled with topical prescription therapy and for whom these treatments are not appropriate.
Dupilumab is a fully-human monoclonal antibody, directed against the shared IL-4 receptor alpha subunit, which blocks signalling from both IL-4 and IL-13.
IL-4 and IL-13 cytokine are needed for initiation and maintenance of the Type 2 helper T-cell (Th2) immune response, which is said to be a critical pathway in allergic inflammation.
National Eczema Association CEO 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, intense itch, sleep disturbances and other challenges.
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“We are thrilled to see the FDA recognising the need to expedite and prioritise potential new options for these patients.”
The FDA provided designation based on positive results from Phase I and Phase II clinical trials.
Sanofi noted that Phase III worldwide clinical trial is ongoing for dupilumab in adults with moderate-to-severe atopic dermatitis.
Duplimab was developed using Regeneron’s pioneering VelocImmune, and is being co-developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyposis.
Image: Atopic dermatitis of the anterior flexural crease of the elbow. Photo: courtesy of James Heilman, MD.