Nemolizumab FDA Approval Status
Last updated by Judith Stewart, BPharm on Oct 18, 2023.
FDA Approved: No
Generic name: nemolizumab
Company: Galderma Laboratories, L.P.
Treatment for: Prurigo Nodularis, Atopic Dermatitis
Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha in development for the treatment of atopic dermatitis and prurigo nodularis.
- Atopic dermatitis is an inflammatory skin disease characterized by skin lesions with intense itching, and prurigo nodularis is a rare, chronic skin condition characterized by thick skin nodules covering large body areas with intense itching.
- Nemolizumab is a monoclonal antibody directed against the IL-31 receptor alpha that works by blocking signaling from IL-31, a key neuroimmune cytokine. IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis. With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 bridges the immune and nervous systems while directly acting on structural cells in the skin.
- In the randomized, double-blind, placebo-controlled phase III OLYMPIA 2 trial studying the efficacy of nemolizumab in prurigo nodularis patients, nemolizumab showed clinically and statistically significant improvement in both primary endpoints compared to placebo after 16 weeks of treatment:
- 38 percent of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions compared to 11 percent in the placebo group.
- 56 percent of nemolizumab-treated patients achieved an at least four-point reduction in itch compared to 21 percent in the placebo group. - A second phase III trial investigating the efficacy of nemolizumab in patients with prurigo nodularis, named OLYMPIA 1, is ongoing.
- Nemolizumab is approved in Japan for pruritus associated with atopic dermatitis and is under clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world.
- Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis.
Development timeline for nemolizumab
Further information
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