FDA Approves Nemluvio for Skin Condition

On Thursday, August 15, 2024, the U.S. Food and Drug Administration (FDA) granted approval for Nemluvio (nemolizumab) for adult patients suffering from prurigo nodularis. This medication is delivered via a prefilled pen for subcutaneous injection and works by inhibiting interleukin-31 cytokine signaling. This cytokine plays a significant role in driving itch and is involved in the inflammation, altered epidermal differentiation, and fibrosis associated with prurigo nodularis.

The approval of Nemluvio is underpinned by data from the phase 3 OLYMPIA 1 and OLYMPIA 2 clinical trials. These trials assessed the efficacy and safety of the medication, which was administered subcutaneously every four weeks to over 500 patients. The results demonstrated that 56% of patients treated with Nemluvio in the OLYMPIA 1 trial and 49% of patients in the OLYMPIA 2 trial achieved at least a 4-point reduction in itch intensity by week 16, compared to just 16% in the placebo groups for both trials. Additionally, at week 4, 41% of Nemluvio-treated patients experienced at least a 4-point reduction in itch intensity, compared to 6% and 7% in the placebo groups of OLYMPIA 1 and OLYMPIA 2, respectively.

Moreover, the trials showed that 26% of Nemluvio-treated patients in OLYMPIA 1 and 38% in OLYMPIA 2 achieved clearance of skin nodules by week 16, in contrast to 7% and 11% in the respective placebo groups. The treatment also yielded significant improvements in sleep disturbance by week 16.

Dr. Shawn Kwatra, M.D., Ph.D., from the University of Maryland School of Medicine in Baltimore and the lead investigator of the OLYMPIA program, expressed optimism about the new treatment option. He noted that many prurigo nodularis patients are in desperate need of rapid relief from itching, which severely impacts their quality of life.

The FDA approval of Nemluvio was granted to Galderma.