The designation was received by Galderma, a global leader in skin health, with whom Chugai made a license agreement for the development and marketing of nemolizumab worldwide with the exception of
Prurigo nodularis is a chronic skin disease with thick skin nodules covering large body areas and associated severe pruritus. It is a rare disease and may affect daily life. 1, 2, 3) Galderma presented results from its Phase 2 clinical study evaluating the safety and efficacy of nemolizumab in prurigo nodularis at the 28th Annual Congress of the
'Nemolizumab is a first-in-class investigational drug targeting IL-31 receptor A, and created by utilizing Chugai's proprietary antibody engineering technology ACT-Ig. I am excited that this 8th BTD for five drug candidates from Chugai research was granted based on the Phase 2 clinical study that Galderma conducted,' said Dr.
Galderma is now preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020. Please refer below for the Galderma's press release regarding this BTD of nemolizumab: Galderma Investigational Therapy, Nemolizumab, Granted FDA Breakthrough Therapy Designation for the Treatment of Patients Suffering from Prurigo Nodularis (A press release issued on
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
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