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 Thursday, 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
