Galderma announced the acceptance of its Biologics License Applications for nemolizumab, a first-in-class monoclonal antibody IL-31 inhibitor, for the treatment of prurigo nodularis in adults and adolescents with moderate-to-severe atopic dermatitis (AD).
The agency, according to a news release, has granted nemolizumab Priority Review, which follows its 2019 status of Breakthrough Therapy (reaffirmed in 2023). Additionally, the European Medicines Agency has also granted Marketing Authorization Applications for nemolizumab for both prurigo nodularis and AD. The manufacturer plans for multiple regulatory submissions in 2024 based on data from the phase 3 OLYMPIA clinical trial program evaluating the safety and efficacy of subcutaneous nemolizumab delivered every 4 weeks in patients with prurigo nodularis. In OLYMPIA, nemolizumab was shown to rapidly improve itch, clear skin nodules, and reduce sleep disturbance after 16 weeks of treatment vs. placebo. OLYMPIA represents the largest clinical trial program to date looking at patients with prurigo nodularis, with more than 500 patients. It also includes a long-term extension study.
Results from another clinical trial program (ARCADIA) also show that nemolizumab was associated with improved skin lesions and rapid improvement in itch (and sleep disturbance) in patients with AD. The drug was well-tolerated in both trial programs and the safety profile was shown to be similar to placebo.
“The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life," Baldo Scassellati Sforzolini, MD, PhD, global head of R&D at Galderma, said in a press release. "We are thankful to the patients and medical experts whose insights informed our clinical trials, which assessed nemolizumab’s ability to reduce the symptoms of itch and skin lesions. We are one step closer to delivering this innovative solution to those in need and look forward to the outcomes of these filing decisions.”
Source: Galderma news release. Published February 15, 2024.