The biological treatment targets one of the main triggers of prurigo nodularis. Trial data demonstrate relief of itching and skin nodule formation in patients with this condition.
The US Food and Drug Administration (FDA) has approved the first monoclonal antibody that inhibits IL-31 cytokine signaling. The biologic is intended for adults with prurigo nodularis, a chronic neuroimmune skin disease. Nemluvio by Galderma ® (Nemolizumab) is approved as a prefilled pen for administration by subcutaneous injection.
The FDA’s decision is based on positive results from two Phase III OLYMPIA clinical trials, OLYMPIA 1 and OLYMPIA 2. The program is the most comprehensive to date conducted against prurigo nodularis, Galderma emphasized.
Nemluvio Phase III trial results
Findings from the program showed that Nemluvio led to a significant improvement in itching and skin nodules by week 16, with a rapid reduction in itching already observed by week 4. A four-point reduction in itching intensity was observed in 41 percent of patients treated with Nemluvio by week 4.
(Nemluvio enables) rapid reduction of itching as early as the fourth week (in patients with prurigo nodularis)”
In addition, 56 percent and 49 percent of study patients, respectively, achieved a reduction in itching intensity of at least four points at week 16.
In addition, at week 16, 26 percent and 38 percent of participants, respectively, had cleared or nearly cleared their skin nodules, compared to seven percent and 11 percent, respectively, among participants who received a placebo.
The researchers concluded that Nemluvio was generally well tolerated and its safety profile was consistent with that of the earlier Phase II study, Galderma said.
“The rapid approval of Nemluvio for the treatment of prurigo nodularis by the U.S. FDA is a first step toward achieving blockbuster platform potential. We are confident that this first-in-class therapy will have a major impact on patients with prurigo nodularis who urgently need more treatment options, and we look forward to potentially offering Nemluvio to patients with other itch-related skin conditions in the near future,” said Dr. Flemming Ørnskov, MPH, Chief Executive Officer of Galderma.
Applications for marketing authorization of Nemluvio for the treatment of prurigo nodularis and atopic dermatitis are currently being reviewed by various regulatory authorities, including the European Medicines Agency (EMA).
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