The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
The FDA on Tuesday signed off on Galderma’s IL-31 blocker nemolizumab for the treatment of adults with the chronic skin disorder prurigo nodularis. The subcutaneous injection will be marketed under the brand name Nemluvio.
According to Galderma, Nemluvio is the first monoclonal antibody approved for prurigo nodularis that specifically targets IL-31 and blocks in downstream signaling. The Swiss company did not specify a timeline for Nemluvio’s launch in its announcement, nor did it reveal pricing for the treatment.
CEO Flemming Ørnskov said in a statement that Galderma is “confident” in Nemluvio’s therapeutic profile and that the first-in-class treatment will be impactful “for patients with prurigo nodularis who urgently need more treatment options.”
Designed to be administered subcutaneously once a month, Nemluvio is a humanized IgG2 monoclonal antibody that binds to a specific region of the IL-31 receptor. Through this mechanism of action, Nemluvio prevents the receptor’s interaction with the naturally occurring IL-31 cytokine which would otherwise drive inflammation, a central pathway in prurigo nodularis.
Tuesday’s approval is backed by data from the Phase III OLYMPIA program, which according to Galderma is the “largest clinical trial program conducted in this indication to date.” In OLYMPIA 1 and OLYMPIA 2, Nemluvio elicited at least a four-point reduction in itch intensity in 56% and 49% of treated patients, respectively. The outcomes, measured at 16 weeks, were statistically significant versus 16% in the placebo groups of both studies.
Nemluvio’s therapeutic benefit in OLYMPIA 1 and OLYMPIA 2 was evident as early as four weeks, at which point 41% of treated patients showed at least a four-point drop in itch intensity scores, compared to 6% and 7% in the respective placebo groups.
The OLYMPIA studies also hit key secondary endpoints, including skin clearance as determined by an investigator’s global assessment scale and reductions in sleep disturbances. Nemluvio was safe and well-tolerated in the OLYMPIA program, which found no new signals of concern.
In addition to prurigo nodularis, Galderma is also proposing Nemluvio as a treatment for atopic dermatitis, the approval for which could potentially unlock a much larger market. The company submitted its regulatory application in this indication in February 2024.
The FDA’s prurigo nodularis approval is Nemluvio’s “first step in achieving its blockbuster platform potential,” Ørnskov said in a statement.
With Tuesday’s approval, Nemluvio will compete against market leader Dupixent (dupilumab), which is among the best-selling drugs not just in the inflammation space but across the industry. Owned by both Sanofi and Regeneron, Dupixent brought in more than $11 billion in sales in 2023.
