BRIEF—Galderma Breakthrough designation

Swiss independent dermatology specialist Galderma today announced that the US Food and Drug Administration has granted Breakthrough Therapy designation to the investigational therapy nemolizumab for the treatment of pruritus associated with prurigo nodularis.

Prurigo nodularis is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus, which frequently leads to a severe quality of life impairment.

Galderma’s nemolizumab is a first-in-class investigational monoclonal antibody that blocks signalling of interleukin (IL)-31.

Nemolizumab met its primary of a greater improvement in peak pruritus Numerical Rating Scale from baseline compared to placebo, as well as significantly improving skin lesions as measured by Investigator Global Assessment.

Galderma is now actively preparing for the initiation of a Phase III pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020.