FDA approves Nemluvio for treatment of prurigo nodularis

Key takeaways:

• The FDA approved Nemluvio (nemolizumab-ilto) to treat adults with prurigo nodularis.
• The approval was supported by results from the phase 3 OLYMPIA clinical trials.

The FDA approved Nemluvio in the form of a prefilled pen for subcutaneous injection for the treatment of prurigo nodularis in adults, Galderma announced in a press release.

“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,” Flemming Ørnskov, MD, MPH, CEO of Galderma, said in the release. “We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases in the near future.”

Nemluvio (nemolizumab-ilto), an interleukin-31 inhibitor, was granted breakthrough therapy designation by the FDA in 2019.

The approval was supported by positive results from the phase 3 OLYMPIA clinical trials, in which patients treated with Nemluvio experienced significant improvements in their itch symptoms and skin nodules by week 16.

In OLYMPIA 1 and OLYMPIA 2, 56% and 49% of Nemluvio-treated patients, respectively, achieved at least a 4-point reduction in itch intensity by week 16 vs. 16% of placebo-treated patients (P < .001). Itch reduction was also observed as early as week 4, with 41% of patients in both trials achieving at least a 4-point reduction in itch intensity vs. 6% and 7% in the placebo groups (P < .001).

IGA 0 or 1 was reached by 26% and 38% of Nemluvio-treated patients in OLYMPIA 1 and OLYMPIA 2, respectively, by week 16 vs. 7% and 11% of the placebo groups (P < .001). More than half of Nemluvio-treated patients in both trials also achieved at least a 4-point reduction in sleep disturbance at week 16 vs. 12% and 21% of the placebo groups (P < .001).

According to the release, the FDA is currently reviewing the biologics license application for Nemluvio for the treatment of moderate to severe atopic dermatitis, with a decision expected this year.