Additional phase 3 trial results confirmed improvement in hives and itching.
The US Food and Drug Administration has accepted a resubmission of the supplemental Biologics License Application for dupilumab for the treatment of chronic spontaneous urticaria in adults and youth aged ≥ 12 years for whom antihistamines are inadequate, according to an announcement from the manufacturer.
Dupilumab, a fully human monoclonal antibody that inhibits the signaling of the interleukin -4 and IL-13 pathways, is currently approved in the United States for multiple indications including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.
Urticaria And Angio-Oedema Urticaria Hives U.S. Food And Drug Administration United States Food And Drug Administration Fda Antihistamine Otolaryngology ENT Specialty Head And Neck Surgery ENT Speciality Asthma Asthmatic Pruritus Pruritis Itch Severe Asthma Uncontrolled Asthma Adolescent Medicine Teens Teenage Teenager Adolescent Health Adolescents
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