Galderma’s Nemluvio Receives FDA Approval for Prurigo Nodularis Treatment

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Galderma's Nemluvio (nemolizumab) for the treatment of adult patients with prurigo nodularis, a chronic skin condition characterized by intense itch and skin nodules.

Mechanism of Action:
Nemluvio works by inhibiting the signaling of IL-31, a cytokine involved in itch, inflammation, and skin hardening in prurigo nodularis.

Clinical Trials:
The approval is based on positive data from the phase 3 OLYMPIA clinical trials, which showed significant reductions in itch intensity and improvements in skin clearance and sleep quality compared to a placebo.

Availability:
Nemluvio will be available in the coming weeks, though pricing details have not been disclosed.

Market Potential:
Galderma is also seeking approval for Nemluvio in moderate to severe atopic dermatitis, which could unlock a larger market.

Prevalence:
Prurigo nodularis is estimated to affect up to 181,000 people in the United States and is often underdiagnosed.