Romosozumab: First Global Approval

Drugs
Anthony Markham

Abstract

Romosozumab (EVENITY™) is a humanised monoclonal antibody against sclerostin being developed by Amgen and UCB for the treatment of osteoporosis. On the basis of favourable results from several phase III trials in postmenopausal women with osteoporosis, and a single trial in men with osteoporosis, romosozumab is being considered for marketing approval in the US, EU and Canada, and was recently approved for marketing in Japan. This article summarizes the milestones in the development of romosozumab leading to this first approval for the treatment of osteoporosis in patients at high risk of fracture.

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Jan 11, 2020·Journal of Population Therapeutics and Clinical Pharmacology Journal De La Thérapeutique Des Populations Et De La Pharamcologie Clinique·Ahmad Shakeri, Christopher Adanty
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