FDA Approves Nemluvio for the Treatment of Adult Patients with Prurigo
Nodularis
Galderma announced the U.S. Food and Drug Administration (FDA) approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.
- 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, and is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.
- 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.
Source: Galderma
