BRUSSELS and THOUSAND OAKS, California, Oct. 18, 2019 /PRNewswire/ -- UCB and Amgen today 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. Romosozumab is a novel bone-builder with a dual effect that increases bone formation and, to a lesser extent, reduces bone resorption (or bone loss).
"Post-menopausal osteoporosis and fragility fractures are a significant women's health issue that's far too often overlooked, with evidence showing that an estimated 77 percent of women aged 67 or older remain undiagnosed and untreated following a fracture(1). This is why new treatment options are so important," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We believe that the Committee's positive opinion is an important step forward to help improve the lives of post-menopausal women with severe osteoporosis who are at high risk of fragility fractures."
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.
"After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,(2) and these fractures can be life-changing," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased by the Committee's opinion, which brings romosozumab one step closer to becoming a new osteoporosis treatment option for patients with severe osteoporosis at high risk of fracture in Europe."
Romosozumab is approved in U.S, for the treatment of osteoporosis in postmenopausal women at high risk for fracture.(3) Romosozumab is also approved in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture, in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture and in Australia for the treatment of osteoporosis in postmenopausal women at high risk of fracture and as a treatment to increase bone mass in men with osteoporosis at high risk of fracture.(4-7)
(1.) Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25(10): 2359-2381. (2.) Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323. (3.) EVENITY(TM) (romosozumab-aqqg) U.S. Prescribing Information https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx [https://c212.net/c/link/?t=0&l=en&o=2511377-1&h=2449337970&u=https%3A%2F%2Fwww.pi.amgen.com%2F%7E%2Fmedia%2Famgen%2Frepositorysites%2Fpi-amgen-com%2Fevenity%2Fevenity_pi_hcp_english.ashx&a=https%3A%2F%2Fwww.pi.amgen.com%2F%7E%2Fmedia%2Famgen%2Frepositorysites%2Fpi-amgen-com%2Fevenity%2Fevenity_pi_hcp_english.ashx] (4.) Pharmaceuticals and Medical Devices Agency Prescription Drug Database http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/ [http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/] (5.) Ministry of Food and Drug Safety, Import Drug License. 20190531. (6.) EVENITY(TM) Product Monograph. Amgen Canada Inc. (June 2019). (7.) Australian Government. Department of Health. Therapeutic Goods Administration Database https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=D3CCEA90E71D6635CA25842A00421D00&agid=(PrintDetailsPublic)&actionid=1 [https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=D3CCEA90E71D6635CA25842A00421D00&agid=(PrintDetailsPublic)&actionid=1]. Accessed October 2019. About EVENITY(®) (romosozumab)
Romosozumab is a bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing romosozumab to either placebo or active comparator in over 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.
UCB, Brussels, Belgium (www.ucb.com [http://www.ucb.com/]) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of EUR 4.6 billion in 2018. UCB is listed on Euronext Brussels . Follow us on Twitter: @UCB_news.
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