Galderma Gets FDA Nod for Nemluvio® for Adult Prurigo Nodularis

ZUG, Switzerland, August 13, 2024 – Galderma has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection aimed at treating adults with prurigo nodularis. The drug received Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 from the FDA, recognizing its potential to significantly improve the treatment of this serious condition.

Prurigo nodularis is a neuroimmune skin disease that is often undiagnosed and is estimated to affect up to 181,000 individuals in the United States. This condition manifests through chronic itch, large skin nodules, and poor sleep quality, significantly burdening those affected. Due to these challenging symptoms, effective alternative treatments are in high demand.

Nemluvio works by inhibiting IL-31 cytokine signaling, which plays a crucial role in causing itch, inflammation, altered epidermal differentiation, and fibrosis associated with prurigo nodularis. The FDA’s approval of Nemluvio is based on the positive outcomes from the phase III OLYMPIA clinical trials, the most comprehensive study conducted for this skin condition to date. These trials demonstrated that Nemluvio significantly improved itch and skin nodules by Week 16, with noticeable reductions in itch as early as Week 4.

The OLYMPIA 1 and OLYMPIA 2 trials assessed the drug’s efficacy and safety when administered subcutaneously every four weeks to more than 500 prurigo nodularis patients. The studies met their primary and key secondary endpoints, showing rapid reductions in itch and sleep disturbances within four weeks of treatment initiation. Nemluvio was found to be generally well-tolerated, with a safety profile consistent with previous phase II trials.

In addition to this approval, the U.S. FDA is also reviewing a Biologics License Application for Nemluvio as a treatment for moderate-to-severe atopic dermatitis, with a decision expected later in the year. Galderma has also submitted marketing authorization applications for Nemluvio for both prurigo nodularis and atopic dermatitis to various regulatory authorities, including the European Medicines Agency and Health Canada, as well as agencies in Australia, Singapore, Switzerland, and the United Kingdom, under the Access Consortium framework.

Nemluvio (nemolizumab-ilto) was originally developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma acquired exclusive rights to develop and market nemolizumab globally, excluding Japan and Taiwan. In Japan, the drug is marketed as Mitchga® and is approved for treating prurigo nodularis and pruritus related to atopic dermatitis across various age groups, including pediatric, adolescent, and adult patients.

Galderma, established in 1981, is a leader in the dermatology sector, operating in approximately 90 countries. The company offers a diverse portfolio of science-based dermatological treatments, including injectable aesthetics, dermatological skincare, and therapeutic dermatology. Galderma is committed to advancing dermatology and addressing the needs of patients and consumers globally.

Prurigo nodularis is a chronic and debilitating neuroimmune skin disease characterized by intense itching and the formation of thick skin nodules across large areas of the body. The condition is often underrecognized and underdiagnosed, with an estimated prevalence affecting up to 181,000 people in the U.S. The persistent itch associated with the disease significantly impacts patients' quality of life, causing sleep disturbances and further reducing overall well-being.