Romosozumab: First Global Approval
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ADISINSIGHT REPORT
Romosozumab: First Global Approval Anthony Markham1
© Springer Nature Switzerland AG 2019
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.
1 Introduction
1.1 Company Agreements and Patent Information
Romosozumab (EVENITY™), a humanised monoclonal antibody against sclerostin, is being developed by Amgen and UCB for the treatment of osteoporosis [1]. Sclerostin, encoded by the SOST gene, is an inhibitor of the canonical Wnt signalling pathway which has a pivotal role in skeletal development, adult skeletal homeostasis, and bone remodelling. Romosozumab binds to sclerostin, inhibiting its activity and leading to bone formation and bone mineral density (BMD) gain [2]. Romosozumab is approved in Japan [3] and is under regulatory review for postmenopausal osteoporosis and male osteoporosis in the USA [4], EU [5] and Canada [6]. Development of romosozumab for fracture healing has been discontinued. The approved adult dosage of romosozumab in Japan is 210 mg administered subcutaneously (SC) once a month for 12 months. Use of romosozumab in patients with hypocalcaemia is contraindicated and, based on results of the ARCH trial (NCT01631214), administration in patients with high risk for ischemic heart disease or cerebrovascular disorder requires caution and should take into consideration the benefits and risks of treatment [3].
Romosozumab was originally developed by Chiroscience, which subsequently merged with Celltech, with the merged group later acquired by and fully integrated into UCB. In May 2002 the former Celltech entered into a collaborative research agreement with Amgen to develop and market an antibody fragment against the sclerostin protein as a treatment for osteoporosis. Under the terms of the agreement, Amgen obtained exclusive worldwide rights to develop and market treatments targeting the sclerostin protein with Celltech responsible for identifying and engineering a high affinity PEGylated antibody fragment against the Sclerostin protein using its SLAM (Selected Lymphocyte Antibody Method) and proprietary antibody fragment technologies. In 2016 this agreement was amended to cover commercialisation rights and responsibilities. Under the amended agreement Amgen obtained rights to commercialise romosozumab for all indications in the US, Japan and Hong Kong, and UCB obtained rights for Europe, China and Brazil, with development costs and future worldwide commercialisation profits and losses related to the collaboration to be shared
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