Galderma's New Skin Treatment Gets FDA Nod, A Victory for Dermatology

Nemluvio received clearance on Tuesday, nearly two years after the FDA approved the first treatment for prurigo nodularis—Sanofi and Regeneron Pharmaceuticals' blockbuster drug Dupixent. Though the two medications operate through different mechanisms, both aim to address the inflammatory causes of this underdiagnosed condition, which not only causes intense itching but also results in the formation of thick, hardened nodules on the skin. Galderma reports that prurigo nodularis may affect up to 180,000 individuals in the U.S.

Galderma acquired the rights to Nemluvio, or nemolizumab, from Chugai Pharmaceutical in 2016. The company progressed the drug to late-stage clinical trials, testing it on more than 500 adults with prurigo nodularis to determine if the treatment could reduce itch severity by at least four points on a scale after four months. In two Phase 3 trials, 56% and 49% of participants treated with Nemluvio achieved this reduction, compared to just 16% in the placebo groups. The company has submitted a request to the FDA for approval of Nemluvio for the treatment of moderate-to-severe atopic dermatitis and anticipates a decision before the end of the year.

Galderma CEO Flemming Ørnskov, who previously led Shire before its acquisition by Takeda Pharmaceuticals, said “The U.S. FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology.”