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The FDA approved the interleukin (IL)-31 monoclonal antibody nemolizumab (Nemluvio) for treating prurigo nodularis, drugmaker on Tuesday.

The approval stipulates use in adults with prurigo nodularis, a skin condition characterized by chronic itch, nodules covering large areas of the body, and poor sleep quality. Driven by IL-31 signaling, involved in itch, inflammation, and fibrosis, prurigo nodularis affects about 180,000 people in the U.S., according to the company.

"I'm looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life," said Shawn Kwatra, MD, of the University of Maryland School of Medicine in Baltimore, in the company statement. "By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules."

Primary support for the approval came from the OLYMPIA 1 and 2 trials, which involved a combined total of more than 500 patients with prurigo nodularis. In the two trials, 26% and 38% of patients, respectively, achieved the primary endpoint of an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) at 16 weeks (range 0-4) compared with 7% and 11% for the placebo groups (P<0.001).

Additionally, 56% and 49% of patients in OLYMPIA 1 and 2 met the other primary endpoint of at least a 4-point improvement in itch intensity on the 10-point Peak Pruritus Numerical Rating Scale at week 16 versus 16% of patients randomized to placebo (P<0.001).

A key secondary endpoint -- a 4-point improvement in sleep disturbance at 16 weeks -- was achieved by 50% and 52% of patients in OLYMPIA 1 and 2, as compared with 12% and 21%, respectively, in the placebo groups (P<0.001).

The most common side effects associated with nemolizumab include headache, skin rashes, and eczema nummular. Nemolizumab may cause serious side effects in some patients, notably hypersensitivity reactions.

Galderma has also submitted an approval application for nemolizumab to treat moderate-to-severe atopic dermatitis.

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