Galderma’s breakthrough drug Nemluvio gains rapid FDA approval for severe itch condition

Galderma has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving Nemluvio (nemolizumab) for the treatment of prurigo nodularis in adults. This approval allows Nemluvio to be administered as a pre-filled pen for subcutaneous injection, providing a new option for patients suffering from this challenging condition. The drug’s approval follows its Breakthrough Therapy Designation in December 2019 and Priority Review status granted in February 2024 by the FDA, underscoring its potential to offer substantial benefits for individuals with severe prurigo nodularis.

The FDA’s decision is based on the successful outcomes of the phase III OLYMPIA clinical trials, which represent the largest clinical trial programme conducted for prurigo nodularis to date. The trials, including OLYMPIA 1 and OLYMPIA 2, involved over 500 patients and demonstrated that Nemluvio significantly reduces both itch intensity and skin nodules. By Week 16 of treatment, Nemluvio showed marked improvement, with reductions in itch observable as early as Week 4.

In the OLYMPIA 1 and OLYMPIA 2 trials, Nemluvio yielded noteworthy results. In OLYMPIA 1, 56% of patients experienced at least a four-point reduction in itch intensity by Week 16, while 49% of those in OLYMPIA 2 achieved similar results. This compares to only 16% in the placebo groups (p<0.001). Furthermore, 41% of patients in both trials noted a reduction in itch intensity by Week 4, compared to just 6% and 7% in the placebo groups (p<0.001). Regarding skin nodules, 26% of patients in OLYMPIA 1 and 38% in OLYMPIA 2 achieved complete or nearly complete clearance by Week 16, compared to 7% and 11% in the placebo groups (p<0.001). Additionally, 50% of patients in OLYMPIA 1 and 52% in OLYMPIA 2 reported a reduction in sleep disturbances by Week 16, compared to 12% and 21% in the placebo groups (p<0.001).

The trials confirmed that Nemluvio was generally well-tolerated, with a safety profile consistent with earlier phase II trials. The rapid onset of itch relief and improvement in skin conditions underscores the drug’s efficacy and safety.

Dr. Shawn Kwattra, M.D., Ph.D., a lead investigator for the OLYMPIA programme, expressed enthusiasm about the approval. He noted, “The approval of Nemluvio represents a major advancement in treating this debilitating condition. By targeting IL-31, Nemluvio effectively addresses the root cause of prurigo nodularis, offering significant relief to patients suffering from severe itch and skin nodules.”

Joseph W. Burnett, Endowed Professor and Chairman of Dermatology at the University of Maryland School of Medicine, highlighted the broader potential of Nemluvio. He emphasised that the approval not only benefits prurigo nodularis patients but also positions Galderma to explore treatment options for other itch-related skin conditions in the future.

The FDA is also reviewing the Biologics License Application for Nemluvio’s use in moderate-to-severe atopic dermatitis, with a decision expected later this year. Galderma’s marketing authorisation applications for Nemluvio are under review by several regulatory bodies, including the European Medicines Agency, Health Canada, and authorities in Australia, Singapore, Switzerland, and the United Kingdom. In Japan, where Nemluvio is marketed as Mitchga, the drug is already approved for prurigo nodularis and pruritus associated with atopic dermatitis.

Nemluvio, initially developed by Chugai Pharmaceutical Co., Ltd., was licensed to Galderma in 2016 for global development and marketing, excluding Japan and Taiwan. In Japan, the drug is marketed as Mitchga and is approved for prurigo nodularis and pruritus related to atopic dermatitis in both children and adults.