December 9, 2019
Galderma today announced that the U.S. Food and Drug Administration (FDA) 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. It frequently leads to a severe quality of life impairment.
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31. Galderma recently presented, at the 28th Annual Congress of the European Academy of Dermatology and Venereology, the results of a Phase 2 study in adult patients with moderate-to-severe prurigo nodularis. Nemolizumab not only met the primary endpoint of a greater improvement in peak pruritus Numerical Rating Scale (PP NRS) from baseline compared to placebo, but also significantly improved skin lesions as measured by Investigator Global Assessment (IGA).
Dr Thibaud Portal, Galderma Global Vice President of Prescription medicines, commented: “With the Phase 2 study results, we were able to provide substantial clinical evidence supporting the Breakthrough Therapy Designation now granted by the U.S. FDA. We are very excited by the prospect of offering a treatment option to doctors, and their patients with prurigo nodularis, where currently there are no registered therapy options. We are fully committed to continue driving forward the overall nemolizumab development program.”
Galderma is now actively preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020.
Earlier this year, Galderma announced the enrollment of the first patients in the Phase 3 pivotal program with nemolizumab in adult patients with moderate-to-severe atopic dermatitis.
About the Breakthrough Therapy Designation
Therapies that are granted Breakthrough Therapy Designation by the U.S. FDA target serious or life-threatening diseases or conditions and provide preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31 receptor alpha, which blocks signaling from IL-31. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com