Galderma has secured FDA approval for a drug it licensed from Chugai Pharmaceutical in 2016 for a chronic skin disease known for its itchy bumps.
On Tuesday, the US regulator greenlit Galderma’s first-in-class anti-IL-31 monoclonal antibody, dubbed nemolizumab, for adults with prurigo nodularis. Nemolizumab will be marketed as a prefilled pen for subcutaneous injection with the brand name Nemluvio.
Last week, Jefferies analysts said they project $2.1 billion in global peak sales for Nemluvio, but most will be driven by $1.5 billion sales potential in atopic dermatitis. The drug is under FDA review for moderate-to-severe atopic dermatitis with a decision expected in December.
The approval in prurigo nodularis is the “first step in achieving [Nemluvio’s] blockbuster platform potential,” Galderma CEO Flemming Ørnskov said in the release.
Prurigo nodularis affects up to 181,000 people in the US and leads to chronic itch, nodules covering large areas of the skin and poor sleep quality, according to Galderma. Meanwhile, atopic dermatitis affects 16.5 million adults in the US, with 6.6 million reporting moderate to severe symptoms.
Nemolizumab was originally developed by Chugai before Galderma licensed it back in 2016 in a deal with undisclosed upfront, milestone and royalty payments.
The drug works by blocking IL-31 cytokine signaling, which is known to play a role in the development of itch, inflammation and hardening of the skin in prurigo nodularis.
Existing biologic treatments for the disease, such as Sanofi’s Dupixent, require biweekly administration while Nemluvio is designed for more convenient monthly injection, Ørnskov previously said.
The prurigo nodularis approval was based on data from Galderma’s 560-participant Phase 3 OLYMPIA clinical trial program. In OLYMPIA 1 and OLYMPIA 2, around 56% and 49% of Nemluvio patients, respectively, hit the primary endpoint of a minimum four-point reduction in itch intensity at 16 weeks versus 16% of placebo patients (p<0.001).
Galderma became the world’s biggest independent global dermatology company in 2019 after a CHF 10.2 billion ($10 billion) carveout of Nestlé Skin Health.
Editor’s note: An earlier version of this story had an incorrect date. The FDA approved Nemluvio on Tuesday.