Galderma’s IL-31 injection wins FDA approval for skin disorder prurigo nodularis
Galderma’s IL-31 injection wins FDA approval for skin disorder prurigo nodularis
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.
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