Immunoglobulin G2, anti-(human sclerostin) (human-mouse monoclonal 785A070802 heavy chain), disulfide with human-mouse monoclonal 785A070802 κ-chain, dimer
- Immunoglobulin G2, anti-(human sclerostin) (humanized monoclonal 785A070802 heavy chain), disulfide with humanized monoclonal 785A070802 κ-chain, dimer
Treatment of osteoporosis
Osteoporosis agent, Sclerostin activity inhibitor
JAPAN APPROVED 2019/1/8, Evenity
In 2016 results from 12 months of a clinical study were reported.
Japan’s Ministry of Health, Labor and Welfare has granted a marketing authorization for romosozumab (EVENITY) for the treatment of osteoporosis in patients at high risk of fracture. Developed by Amgen and UCB, romosozumab is a humanized IgG2 monoclonal antibody that targets sclerostin. The approval in Japan is based on results from the Phase 3 FRAME and BRIDGE studies, which included 7,180 postmenopausal women with osteoporosis and 245 men with osteoporosis, respectively.
A biologics license application (BLA) for romosozumab as a treatment of osteoporosis in postmenopausal women at high risk for fracture was submitted to the U.S. Food and Drug Administration (FDA) in July 2016, but additional safety and efficacy data was requested in the FDA’s complete response letter, as announced by Amgen and UCB in July 2017. In July 2018, Amgen and UCB announced that the BLA had been resubmitted. In addition to data from early-stage clinical studies, the original BLA included data from the Phase 3 FRAME study. The resubmitted BLA includes results from the more recent Phase 3 ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the Phase 3 BRIDGE study. The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee is scheduled to review data supporting the BLA for romosozumab at a meeting on January 16, 2019.
The European Medicines Agency is also currently reviewing a marketing application for romosozumab.
Commercial production of cell culture-derived products (for example, protein-based products, such as monoclonal antibodies (mAbs)), requires optimization of cell culture parameters in order for the cells to produce enough product to meet clinical and commercial demands. However, when cell culture parameters are optimized for improving productivity of a protein product, it is also necessary to maintain desired quality specifications of the product such as glycosylation profile, aggregate levels, charge heterogeneity, and amino acid sequence integrity (Li, et al., 2010 , mAbs., 2(5):466-477).
- “Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab” (PDF). American Medical Association.
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- Cosman; et al. (2016). “Romosozumab Treatment in Postmenopausal Women with Osteoporosis”. The New England Journal of Medicine. 375: 1532–1543. doi:10.1056/NEJMoa1607948. PMID 27641143.
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)
- Bone Loss Drug Effective, But is it Safe? Oct 2017
|Source||Humanized (from mouse)|
|Chemical and physical data|
|Molar mass||145.9 kg/mol|
///////////Romosozumab, ロモソズマブ (遺伝子組換え) , JAPAN 2019, Monoclonal antibody, Osteoporosis, AMG 785
Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems
|Bone (“-os-“, “-s(o)-“)||
|Angiogenesis inhibitor (“-anibi-“)||
|Growth factor (“-gr(o)-“)||