FDA Approves Galderma's Nemluvio for Adult Prurigo Nodularis

The US Food and Drug Administration (FDA) has granted approval to Galderma's monoclonal antibody, Nemluvio (nemolizumab), for the treatment of adults with prurigo nodularis. Prurigo nodularis is a chronic skin disorder that affects up to 181,000 individuals in the United States. This condition is marked by the presence of thick skin nodules and an intense itch.

Nemluvio is available as a pre-filled pen for subcutaneous injection and is formulated to target the underlying cause of prurigo nodularis by inhibiting the signaling of the neuroimmune cytokine IL-31. This innovative approach aims to alleviate the symptoms by addressing the root cause of the disorder.

The FDA’s approval was based on the promising findings from two late-stage clinical trials, OLYMPIA 1 and OLYMPIA 2. These trials assessed the efficacy and safety of Nemluvio administered every four weeks in more than 500 patients suffering from prurigo nodularis. Both studies achieved their primary endpoints, with significant improvements noted in patients treated with Nemluvio compared to those who received a placebo.

In OLYMPIA 1, 56% of patients treated with Nemluvio experienced at least a four-point reduction in itch intensity by the 16th week, whereas only 16% of the placebo group saw similar results. In OLYMPIA 2, the figures were 49% for the Nemluvio group compared to 16% for the placebo group. Furthermore, a notable percentage of patients achieved clearance or near-clearance of skin nodules: 26% in OLYMPIA 1 and 38% in OLYMPIA 2, in contrast to 7% and 11% in the placebo groups, respectively.

The secondary endpoints were also successfully met, including a reduction in itch intensity by the fourth week of treatment. Moreover, Nemluvio was well-tolerated by patients, adding to its safety profile.

Shawn Kwatra, the lead investigator of the OLYMPIA program at the University of Maryland School of Medicine, expressed his satisfaction with the FDA approval. He emphasized the importance of this new treatment option for his patients, who are in dire need of rapid itch relief to improve their quality of life. Kwatra highlighted that by blocking IL-31 signaling, Nemluvio effectively and safely reduces both itch and skin nodules, addressing a crucial driver of prurigo nodularis.

In addition to prurigo nodularis, the FDA is currently evaluating Nemluvio for the treatment of 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 in multiple regions, including the European Union and the United Kingdom. The drug was initially developed by Chugai Pharmaceutical.

This approval marks a significant advancement in the treatment options available for prurigo nodularis and potentially for atopic dermatitis, offering new hope for patients suffering from these debilitating conditions.