FDA Approves Galderma's Nemluvio for Prurigo Nodularis

The FDA has approved Galderma’s Nemluvio (nemolizumab-ilto) for treating adults with prurigo nodularis. This development is seen by CEO Flemming Ørnskov as a significant step towards realizing the drug's potential as a successful monoclonal antibody treatment. Nemluvio, initially in-licensed from Chugai Pharmaceutical in 2016, functions by blocking the IL-31 neuroimmune cytokine, which is responsible for triggering itch and is implicated in inflammation, altered skin differentiation, and fibrosis in prurigo nodularis patients.

Additionally, the FDA is currently reviewing Nemluvio for treating moderate-to-severe atopic dermatitis, with a decision expected later this year. This second indication presents a more crowded market but offers greater sales potential. Analysts at Jefferies estimate peak revenue of $1.5 billion out of a total $2.1 billion for Nemluvio. Earlier this year, FirstWord conducted an interview with an expert who highlighted Nemluvio’s rapid itch relief as its primary advantage in the atopic dermatitis market.

The approval of Nemluvio for prurigo nodularis is based on positive results from the Phase III OLYMPIA 1 and OLYMPIA 2 clinical trials. These trials assessed the efficacy of Nemluvio administered subcutaneously every four weeks. In the OLYMPIA 1 trial, 56% of patients treated with Nemluvio achieved at least a four-point reduction in itch intensity by week 16, compared to 16% in the placebo group. Similarly, in the OLYMPIA 2 trial, 49% of Nemluvio-treated patients experienced the same level of itch reduction, compared to 16% in the placebo group. Remarkably, reductions in itch were noted as early as the fourth week of treatment.

Dr. Shawn Kwatra, the lead investigator in these studies, expressed optimism about offering Nemluvio to prurigo nodularis patients in his practice. He emphasized the urgent need for fast-acting relief from itch, which significantly deteriorates patients' quality of life.

In addition to the United States, Nemluvio is under review for prurigo nodularis and atopic dermatitis in Europe, Canada, and Australia. The drug received approval in Japan in 2022 under the name Mitchga for treating itch associated with atopic dermatitis. Earlier this year, its use in Japan was extended to include prurigo nodularis. Maruho Co. holds the development and marketing rights to Nemluvio in Japan for dermatological uses.

The approval of Nemluvio marks a pivotal moment for Galderma as it ventures into addressing severe skin conditions like prurigo nodularis and atopic dermatitis. With promising clinical trial results and ongoing international reviews, Nemluvio has the potential to become a leading treatment option for patients struggling with these challenging dermatological conditions. The upcoming FDA decision on its use for atopic dermatitis is particularly anticipated, with the possibility of expanding its impact and market reach even further.

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