Galderma also presented results from an analysis of maintenance data from two pivotal phase III trials of nemolizumab (administered with background topical corticosteroid therapy or topical calcineurin inhibitors) in adolescent and adult patients with moderate to severe atopic dermatitis (ARCADIA 1 and ...
The approval is based on positive results from the phase III OLYMPIA clinical trials – the largest clinical trial program conducted in this condition to date – in which Nemluvio demonstrated significant and clinically meaningful improvements in itch and skin nodules at Week 16, with rapid reduction...
The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator’s global assessment score of clear (0) or a...
The ARCADIA program included two identical, pivotal phase III clinical trials which enrolled more than 1,500 patients – ARCADIA 1 and ARCADIA 2. The trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks, compared to placebo, in adolescent and adult p...
This positive CHMP opinion is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs in atopic dermatitis and prurigo nodularis, respectively. The phase III ARCADIA 1 and 2 trials evaluated the efficacy and safety of nemolizumab in 1,728 adolescent and adult patie...