> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Galderma BLA for Nemluvio Approved
- URL: https://www.fdaweb.com/galderma-bla-for-nemluvio-approved/
- Published: 2024-08-13T12:00:00.000Z
- Updated: 2026-09-14T14:38:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157555

FDA has approved a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis. The underdiagnosed neuroimmune skin disease is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality, the company says. Galderma says Nemluvio works by inhibiting IL-31 cytokine signaling, which is known cause inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue) in prurigo nodularis.

Approval was based on data from the Phase 3 OLYMPIA clinical trials 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, according to the company. “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,” it says. Nemluvio was said to be generally well tolerated, and its safety profile was consistent with earlier Phase 2 trial data.