The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) to treat adults with prurigo nodularis.

Estimated to affect up to 181,000 people in the US, prurigo nodularis is chronic skin condition characterised by thick skin nodules and intense itch.

Nemluvio, which has been approved as a pre-filled pen for subcutaneous injection, is designed to address the underlying cause of the disorder by inhibiting signalling of the neuroimmune cytokine IL-31.

The US regulator’s decision was supported by positive results from the late-stage OLYMPIA 1 and OLYMPIA 2 trials, which evaluated the efficacy and safety of Nemluvio, given every four weeks, in more than 500 patients with prurigo nodularis.

Both studies met their primary endpoints, with 56% and 49% of Nemluvio-treated patients in OLYMPIA 1 and 2, respectively, achieving at least a four-point reduction in itch intensity at week 16 compared to 16% in both placebo groups.

Additionally, 26% and 38% of patients receiving Nemluvio in OLYMPIA 1 and 2, respectively, reached clearance or almost-clearance of skin nodules at week 16, compared to 7% and 11% in the placebo groups.

All key secondary endpoints were also met, including reduction in itch intensity at week four, and the drug was shown to be well tolerated.

Shawn Kwatra, lead investigator of the OLYMPIA programme, University of Maryland School of Medicine, said: “I’m delighted that Nemluvio has received US FDA approval and 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.

“By inhibiting the signalling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”

Beyond prurigo nodularis, the FDA is reviewing Nemluvio as a treatment for moderate-to-severe atopic dermatitis, with a decision anticipated later this year.