FDA Approves Nemluvio for Prurigo Nodularis

THURSDAY, Aug. 15, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Nemluvio (nemolizumab) for adult patients living with prurigo nodularis.

Nemluvio, administered as a prefilled pen for subcutaneous injection, inhibits interleukin-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis in prurigo nodularis.

The approval is based on data from the phase 3 OLYMPIA 1 and OLYMPIA 2 clinical trials that evaluated the efficacy and safety of Nemluvio administered subcutaneously every four weeks in more than 500 patients. Specifically, 56 and 49 percent of Nemluvio-treated patients in OLYMPIA 1 and 2, respectively, achieved at least a 4-point reduction in itch intensity at week 16 compared with the 16 percent seen in both placebo groups. Additionally, 41 percent of Nemluvio-treated patients achieved at least a 4-point reduction in itch intensity at week 4 versus 6 and 7 percent in the placebo groups. Lastly, 26 and 38 percent of Nemluvio-treated patients in OLYMPIA 1 and 2, respectively, reached clearance of skin nodules at week 16 compared with 7 and 11 percent in the placebo groups. Significant benefits were also seen for sleep disturbance at week 16.

"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," Shawn Kwatra, M.D., Ph.D., from the University of Maryland School of Medicine in Baltimore and lead investigator of the OLYMPIA program, said in a statement.

Approval of Nemluvio was granted to Galderma.

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