First-in-class therapy approved for chronic skin disease

The US Food and Drug Administration (FDA) has approved the first monoclonal antibody that inhibits IL-31 cytokine signalling. The biologic is indicated for adults with prurigo nodularis, a chronic neuroimmune skin disease. Galderma’s Nemluvio ^® (nemolizumab) is authorised as a pre-filled pen for administration via subcutaneous injection.

FDA’s decision is based on positive results from two Phase III OLYMPIA clinical trials, OLYMPIA 1 and OLYMPIA 2. The programme is the largest to be conducted for prurigo nodularis to date, Galderma highlighted.

Results from the Nemluvio Phase III studies

Findings from the programme revealed that Nemluvio enabled significant improvements in itch and skin nodules at Week 16, with rapid reductions in itch observed as early as Week 4. A four-point reduction in itch intensity at Week 4 was observed in 41 percent of patients given Nemluvio.

Furthermore, 56 percent and 49 percent of patients in the trials achieved at least a four-point reduction in itch intensity at Week 16.

In addition, 26 percent and 38 percent of participants attained clearance or almost-clearance of skin nodules at Week 16. This was compared to seven percent and 11 percent in those given placebo.

The investigators found that Nemluvio was generally well tolerated. Its safety profile was consistent with the earlier Phase II trial, Galderma stated.

“The US FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential. 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,” Dr Flemming Ørnskov, MPH, Chief Executive Officer, Galderma.

Marketing authorisation applications for Nemluvio for the treatment of both prurigo nodularis and atopic dermatitis are being reviewed by various regulators, including the European Medicines Agency (EMA).