Ad hoc announcement pursuant to Art. 53 LR
- Nemluvio® (nemolizumab) is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis1-3
- Prurigo nodularis is a chronic skin condition that is estimated to affect up to 181,000 people in the United States, and is characterized by persistent, intense itch4-8
- The U.S. Food and Drug Administration granted Nemluvio Priority Review for the treatment of prurigo nodularis in February 2024, following its Breakthrough Therapy Designation in 2019
- Further marketing authorization applications are under regulatory review by multiple regulatory authorities, including the European Medicines Agency and Health Canada
ZUG, Switzerland--BUSINESS WIRE--
Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.1 Nemluvio was granted Breakthrough Therapy Designation in December 2019 and Priority Review in February 2024 by the U.S. FDA - a status reserved for medicines with the potential to significantly improve the treatment of serious conditions.
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Prurigo nodularis is an underdiagnosed neuroimmune skin disease which is estimated to affect up to 181,000 people in the United States.7,8 This condition is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.5,9 Given the significant burden on patients, there is a need for alternative treatment options that may effectively relieve key signs and symptoms of the disease.10 Nemluvio specifically inhibits IL-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.1-3,11,12
"The U.S. FDA's rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We're confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases in the near future." FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA |
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 reductions in itch observed as early as Week 4.1,13-16
The phase III OLYMPIA 1 and OLYMPIA 2 clinical trials evaluated the efficacy and safety of Nemluvio administered subcutaneously every four weeks in more than 500 patients with prurigo nodularis.13-16 The trials met both their primary and key secondary endpoints, demonstrating that:
- 56% and 49% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in itch intensity at Week 16, as measured by the peak-pruritus numerical rating scale, compared to 16% in both placebo groups (p1
- 41% of Nemluvio-treated patients in OLYMPIA 1 and 2 achieved at least a four-point reduction in itch intensity at Week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p1
- 26% and 38% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, reached clearance (investigator's global assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at Week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (p1
- 50% and 52% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in sleep disturbance at Week 16, as measured by the sleep disturbance numerical rating scale, compared to 12% and 21% in the placebo group (p15,16
The trials also met all other key secondary endpoints, confirming rapid reduction of itch due to prurigo nodularis, and sleep disturbance, within four weeks of treatment initiation.1,15,16 Nemluvio was generally well tolerated, and its safety profile was consistent with the phase II trial, and between the OLYMPIA 1 and 2 trials.1,15,16
"I'm delighted that Nemluvio has received U.S. FDA approval and I'm looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life. By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules." DR. SHAWN KWATRA, M.D., PH.D. LEAD INVESTIGATOR OF OLYMPIA PROGRAM JOSEPH W. BURNETT ENDOWED PROFESSOR AND CHAIRMAN OF DERMATOLOGY UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE |
The U.S. FDA has also accepted for review the Biologics License Application for Nemluvio for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later this year. Galderma's marketing authorization applications for Nemluvio in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the European Medicines Agency and Health Canada, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework. Further submissions to other regulatory authorities will continue throughout 2024.
