Nemolizumab Approved for Adults with Prurigo Nodularis

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis.

The approval marks a huge milestone for nemolizumab, which recently demonstrated significant itch-relief in clinical trials last month in adolescent and adult patients with moderate-to-severe atopic dermatitis. Nemluvio is injected subcutaneously in a single dose using a pre-filled pen.

Different treatments — such as strong steroid creams and antihistamines, and in severe cases, immune-suppressing medications, light therapy or advanced therapies like thalidomide or drugs targeting itch signals — have been used in the treatment of prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

Nemluvio is the first therapy that specifically targets IL-31 cytokine signaling, a neuroimmune mechanism central to the disease’s pathogenesis.

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In a press release video, Shawn Kwatra, MD, professor and chair of dermatology in the Department of Dermatology at the University of Maryland School of Medicine, explained that IL-31 is often referred to as the “master itch cytokine.” Studies have shown that the amount of IL-31 injected is directly correlated to the amount of itchiness, making IL-31 a very good target to control itch and inflammation, stated Dr. Kwatra.

Prurigo nodularis is an underdiagnosed condition affecting up to 181,000 people in the US. The disease is characterized by intense itching, the formation of nodules on the skin and often leads to disrupted sleep and a reduced quality of life. Dr. Kwatra noted that collectively, the disease has a severe impact on patients’ mental health.

Nemluvio’s FDA approval was supported by positive data from the Phase III OLYMPIA trials, which represent the most extensive study program conducted for the condition to date. The trials included over 500 patients and demonstrated that Nemluvio provided significant relief from itching and reduced the severity of skin nodules. Patients received Nemluvio or a placebo via subcutaneous injection every four weeks over a period of 16 to 24 weeks

Notably, 56 percent of patients in the OLYMPIA 1 trial and 49 percent in the OLYMPIA 2 trial reported a substantial reduction in itch intensity after 16 weeks of treatment compared to 16 percent in the placebo groups. Nemluvio was effective in reducing the severity of skin nodules, with 26 percent and 38 percent of patients in OLYMPIA 1 and 2, respectively, achieving clear or nearly clear skin by Week 16. A significant percentage of patients also reported reduced sleep disturbances by Week 16 in both clinical trials.

In addition to its approval in the US, Nemluvio is currently under regulatory review at several international authorities, including the European Medicines Agency (EMA) and Health Canada. Galderma’s CEO, Flemming Ørnskov, MD, MPH, noted the possibility of expanding Nemluvio’s use to other itch-related skin diseases.