DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Romosozumab
ロモソズマブ (遺伝子組換え)
AMG 785
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
| Formula |
C6452H9926N1714O2040S54
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|---|---|
| CAS |
909395-70-6
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| Mol weight |
145875.6186
|
Monoclonal antibody
Treatment of osteoporosis
Osteoporosis agent, Sclerostin activity inhibitor
JAPAN APPROVED 2019/1/8, Evenity
Romosozumab (AMG 785) is a humanized monoclonal antibody that targets sclerostin for the treatment of osteoporosis.[1]
Romosozumab was originally discovered by Chiroscience,[2] which was acquired by Celltech (now owned by UCB).[3] Celltech entered in a partnership with Amgen in 2002 for the product’s development.[4]
In 2016 results from 12 months of a clinical study were reported.[5]
Some results from the FRAME[6] and ARCH clinical studies were reported on in 2017.[7]
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.
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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).
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References
- ^ “Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab” (PDF). American Medical Association.
- ^ Quested, Tony (June 7, 2015). “Cream of life science entrepreneurs’ first venture was selling doughnuts”. Business Week. Cambridge, England: Q Communications. Retrieved December 24, 2018.
- ^ Osteocyte control of bone formation via sclerostin, a novel BMP antagonist. EMBO J. 2003 Dec 1;22(23):6267-76.
- ^ Celltech group Annual Report and Accounts 2002
- ^ 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
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Sclerostin |
| Clinical data | |
| ATC code | |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| ChemSpider |
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| KEGG | |
| Chemical and physical data | |
| Formula | C6452H9926N1714O2040S54 |
| 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
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Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems
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| Angiogenesis inhibitor (“-anibi-“) |
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New Drug Approvals 
