FDA approves for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis – Galderma

Galderma announced that the FDA has 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 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. This condition is characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality. Given the significant burden on patients, there is a need for alternative treatment options that may effectively relieve key signs and symptoms of the disease. 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 FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who urgently need more treatment options and look forward to potentially bringing Nemluvio to patients with other itch-related skin diseases in the near future.”

The approval is based on positive results from the phase III OLYMPIA clinical 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.

The trials met both their primary and key secondary endpoints, demonstrating that: i. 56% and 49% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in itch intensity at Week 16, as measured by the peak-pruritus numerical rating scale, compared to 16% in both placebo groups (p<0.001) (primary endpoint). ii. 41% of Nemluvio-treated patients in OLYMPIA 1 and 2 achieved at least a four-point reduction in itch intensity at Week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p<0.001) (key secondary endpoint). iii. 26% and 38% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, reached clearance (investigator’s global assessment [IGA] 0) or almost-clearance (IGA 1) of skin nodules at Week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (p<0.001) (primary endpoint). iv. 50% and 52% of Nemluvio-treated patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in sleep disturbance at Week 16, as measured by the sleep disturbance numerical rating scale, compared to 12% and 21% in the placebo group (p<0.001) (key secondary endpoint).

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. Nemluvio was generally well tolerated, and its safety profile was consistent with the phase II trial, and between the OLYMPIA 1 and 2 trials.