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.
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
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“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
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