Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 20 |
| INN | Romosozumab |
| Status | Approved |
| Drug code(s) | AMG 785, CDP-7851 |
| Brand name | EVENTIY |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Sclerostin |
| Indications of clinical studies | Postmenopausal Osteoporosis, Fracture Healing |
| Primary therapeutic area | Skeletal disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 01, 2006 |
| Start of Phase 2 | |
| Start of Phase 3 | March 15, 2012 |
| Date BLA/NDA submitted to FDA | July 19, 2016 |
| Year of first approval (global) | 2019 |
| Date of first US approval | April 09, 2019 |
| INN, US product name | Romosozumab, romosozumab-aqqg |
| US or EU approved indications | Treatment of osteoporosis in postmenopausal women at high risk for fracture |
| Company | UCB |
| Licensee/Partner | Amgen |
| Comments about company or candidate | FY 2019 FDA report to congress: 1st cycle 11.8 months; sponsor 11.9 months; 2nd cycle 9.0 months First approved in Japan on January 8, 2019, approved in EU in Dec 2019. Dec 2019: Approved in EU. October 18, 2019: UCB and Amgen announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke. The CHMP’s recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by year-end 2019. July 2019: UCB appealed EMA's negative opinion. The European Medicines Agency recommended the refusal of the marketing authorisation for Evenity, a medicine intended for the treatment of osteoporosis. The Agency issued its opinion on 27 June 2019. The company that applied for authorisation, UCB Pharma S.A., may ask for re-examination of the opinion within 15 days of receiving the opinion. The Agency was concerned because the results suggested that patients given Evenity had an increased risk of serious effects on the heart or circulatory system, such as heart attacks or strokes. In addition, when all the data were looked at together, there were more deaths in patients aged over 75 years given the medicine. As it was unclear why the medicine appeared to increase the risk of heart and circulatory problems, and there was no obvious group of patients in whom the risk of these was lower, measures to reduce the risk could not readily be put in place. Approved in the US on April 9, 2019. First approved in Japan on January 8, 2019. An FDA advisory committee voted 18-1 in favor of Amgen's Evenity, or romosozumab, as a treatment for postmenopausal women with osteoporosis who are deemed to be at high risk for bone fractures. AMGN along with European partner UCB announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review its biologics license application (BLA) for Evenity (romosozumab) on Jan 16, 2019. J uly 12, 2018: Amgen and UCB resubmitted BLA to FDA. July 2017: A complete response letter was issued by the FDA to Amgen and UCB regarding its biologics license application for Evenity, or romosozumab, intended to treat osteoporosis. The letter requires resubmission of the application to include efficacy and safety data from a Phase III trial assessing Evenity in men with osteoporosis in addition to efficacy data from a late-stage study of postmenopausal women with osteoporosis included in the original submission. PDUFA date: July 19, 2017. (Rolling?) BLA submission announced July 21, 2016. Primary endpoint met in Phase 3 STRUCTURE study. Partnership with Astellas for marketing in Japan. The romosozumab IND (100391) was opened in November 2006 (as per BLA document). |
| Full address of company | Allée de la Recherche, 60 1070 Brussels Belgium Europe Belgium https://www.ucb.com/contact |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |