Galderma’s IL-31 Blocker Nemluvio Gains FDA Approval for Prurigo Nodularis

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

Mechanism of Action:
Nemluvio is a monoclonal antibody that specifically inhibits the signaling of IL-31, a cytokine involved in itch and inflammation in prurigo nodularis.

Clinical Trials:
The approval is based on positive outcomes from the Phase III OLYMPIA studies, which demonstrated significant improvements in itch and skin nodules, with some patients experiencing relief as early as four weeks.

Administration:
Nemluvio is administered subcutaneously once a month and has been shown to be well-tolerated with a consistent safety profile.

Market Potential:
Nemluvio is expected to compete with market leader Dupixent (dupilumab) and has the potential to achieve blockbuster status, with further regulatory reviews ongoing for its use in atopic dermatitis.

Global Development:
Galderma obtained exclusive development and marketing rights for Nemluvio globally, excluding Japan and Taiwan, where it is marketed as Mitchga®.

Future Indications:
In addition to prurigo nodularis, Nemluvio is under review for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later in 2024.