Galderma, a global dermatology company, has received filing acceptances for its breakthrough treatment nemolizumab. The drug is designed to treat prurigo nodularis and moderate-to-severe atopic dermatitis in adolescents and adults. It received regulatory nods from authorities in Australia, Singapore, Switzerland, and the United Kingdom via the Access Consortium framework.
Progress Towards Regulatory Approval
Following filing acceptances by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in February 2024, Galderma has now secured approvals for nemolizumab in four additional countries. This achievement is backed by promising data from the phase III OLYMPIA and ARCADIA clinical trial programs. Galderma expects a decision from the Access Consortium by next year and continues to pursue regulatory submissions in other countries.
Quote: “These four new filing acceptances once again reinforce the potential blockbuster status of nemolizumab, which has shown great promise in both prurigo nodularis and atopic dermatitis,” said Baldo Scassellati Sforzolini, M.D., Ph.D., Global Head of R&D at Galderma. “We are looking forward to finally bringing this long-awaited therapy to patients as soon as possible.”
Nemolizumab: A Breakthrough Therapy
Nemolizumab specifically inhibits IL-31 signalling to provide rapid and sustained relief from the persistent and burdensome itching associated with both prurigo nodularis and atopic dermatitis.
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Prurigo Nodularis:
The phase III OLYMPIA clinical trials evaluated nemolizumab’s efficacy in treating prurigo nodularis, meeting all primary and secondary endpoints. The results showed rapid improvement in itch, clearance of skin nodules, and reduction of sleep disturbances, with sustained effects for up to a year.
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Atopic Dermatitis:
The phase III ARCADIA clinical trials demonstrated nemolizumab’s efficacy in adolescents and adults with moderate-to-severe atopic dermatitis. Patients experienced rapid improvement in skin lesions, itching, and sleep disturbance, significantly enhancing their quality of life.
Understanding Prurigo Nodularis and Atopic Dermatitis
Prurigo Nodularis:
A rare and chronic condition characterised by intensely itchy nodules on the skin. Patients experience persistent itch, leading to excessive scratching and severe impairment of sleep and quality of life.
Atopic Dermatitis:
A common and chronic form of eczema affecting more than 230 million people worldwide, with varying prevalence across geographies. The disease presents as inflammatory skin lesions with persistent pruritus, frequent infections, and disrupted sleep. It also impacts mental health, increasing the risk of anxiety, depression, and cognitive dysfunction.
Role of IL-31 in Disease Pathogenesis
IL-31, a neuroimmune cytokine, is a central mediator in the pathogenesis of atopic dermatitis. It drives inflammation, itch, and skin abnormalities by:
- Triggering neuronal growth and branching of sensory neurons, resulting in increased density of the skin neuronal network. It may also increase the sensitivity of these neurons
to itch-inducing stimuli. - Activating Immune Cells to release proinflammatory cytokines and amplifying circuits between epithelial surfaces, nerves and immune cells resulting in inflammation.
- Disrupting Skin Barrier. Inhibits filaggrin expression, leading to skin barrier dysfunction.
Nemolizumab’s targeted inhibition of IL-31 signalling provides rapid and significant relief from these symptoms, offering a promising treatment option for millions of patients suffering from these debilitating conditions.
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except in Japan and Taiwan. In Japan, nemolizumab is approved for treating pruritus associated with atopic dermatitis and is in development for prurigo nodularis. Nemolizumab is under regulatory review for the treatment of patients with prurigo nodularis and moderate-to-severe atopic dermatitis by the U.S. Food and Drug Administration and European Medicines Agency, as well as in Australia, Singapore, Switzerland, and the United Kingdom via the Access Consortium framework. Galderma has not received regulatory approval for nemolizumab for any indication in any country.
Conclusion
Accepting nemolizumab filings by regulatory authorities worldwide marks a pivotal step in addressing the unmet needs of patients with prurigo nodularis and atopic dermatitis. Galderma’s continued progress towards approvals will potentially relieve millions who struggle daily with these challenging skin conditions.
