The European Commission has approved nemolizumab (Nemluvio, Galderma) for the treatment of both moderate-to-severe atopic dermatitis (AD) and prurigo nodularis (PN) in the European Union (EU).
The first-in-class interleukin (IL)-31 blocker is now approved for subcutaneous use for the treatment of moderate-to-severe AD in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe PN who are candidates for systemic therapy in EU.
This approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, in which nemolizumabsignificantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe AD and adults with PN, respectively.
Results from the ARCADIA 1 and ARCADIA 2 trials demonstrated that patients treated with nemolizumab, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), showed statistically significant improvements on skin clearance in both co-primary endpoints at Week 16, when compared to placebo +TCS/TCI. The trials also met all key secondary endpoints, confirming significant responses on itch as early as Week 1 and statistically significant improvements in sleep disturbance.
Both co-primary endpoints were also met in the OLYMPIA 1 and OLYMPIA 2 clinical trials, where nemolizumab monotherapy demonstrated significant and clinically meaningful improvements on itch and skin lesions at Week 16, when compared to placebo.The trials met all key secondary endpoints, showing rapid reduction in itch due to PN and sleep disturbance within four weeks of treatment initiation.
Nemolizumab was well tolerated in all trials, and its safety profile was generally consistent with earlier data, and between trials.
“Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms, including chronic itch, skin lesions, poor sleep quality and mental health conditions,” says Diamant Thaçi, MD, lead investigator of the ARCADIA long-term extension analysis and Professor at the University of Lubeck in Germany., in a news release. “With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly, and effectively ease the key symptoms of these diseases and therefore the burden on patients’ lives.”
“Nemolizumab’s benefits have been demonstrated in its comprehensive clinical trial programs in both atopic dermatitis and prurigo nodularis, including the OLYMPIA 1 and 2 studies, which make up the largest completed pivotal program in prurigo nodularis to date,” adds Sonja Ständer, MD, a Professor of Dermatology and Neurodermatology at the University of Münster in Münster , Germany and lead investigator for the OLYMPIA stusies in Europe. “These clinical data, plus its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic solution for dermatologists to support their patients.”
Nemolizumab is also approved by the U.S. Food and Drug Administration for the treatment of atopic dermatitis and prurigo nodularis. It is under review for the treatment of both diseases by several additional regulatory authorities around the world, including Canada, Brazil, and South Korea, and via the Access Consortium framework in countries such as Australia, Singapore and Switzerland. Further submissions to other regulatory authorities are ongoing.
