The U.S. FDA has approved Galderma's nemolizumab, branded Nemluvio, as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis, a neuroimmune skin disease.
Prurigo nodularis, an underdiagnosed disease estimated to affect up to 181,000 people in the U.S., 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.
The approval is based on positive results from the phase 3 OLYMPIA trials – the largest clinical trial program conducted in this condition to date – 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 Galderma.
Switzerland-based Galderma picked up the asset through a 2016 licensing deal with Chugai Pharmaceutical for an undisclosed amount. Galderma is betting on its blockbuster potential, with CEO Flemming Ornskov calling the approval of Nemluvio in prurigo nodularis a "first step." Further marketing authorization applications are under regulatory review by the EMA and Health Canada. The FDA is currently reviewing the drug's application in moderate to severe atopic dermatitis.
