UCB and Amgen Provide Regulatory Update on Status of EVENITY® (romosozumab) in the EU
Brussels, Belgium and Thousand Oaks, Calif. (28 June) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced the companies have been informed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorisation Application for EVENITY® (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP.
“We are disappointed with the CHMP opinion and believe that the body of evidence submitted supports a positive benefit:risk profile for romosozumab and its use in helping to address the urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in postmenopausal women with severe osteoporosis at high risk of fracture,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “Together with Amgen we will seek a re-examination of the CHMP opinion. The re-examination process gives us the opportunity to clarify our position on the submitted data with the goal of making romosozumab available to postmenopausal women at high risk of fracture in the EU.”
The opinion is based on results from a large development program including three pivotal Phase 3 studies comprised of over 11,000 patients: FRAME, including 7,180 postmenopausal women with osteoporosis at risk for fracture;1 ARCH, including 4,093 postmenopausal women with severe osteoporosis at high risk for fracture;2 and BRIDGE, including 245 men with osteoporosis.3
“After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,4 and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a new treatment option with 12 monthly doses to reduce their risk of a fracture,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are disappointed by the Committee’s opinion and continue to believe that romosozumab has a positive benefit:risk profile. Amgen and UCB remain committed to working with regulatory authorities worldwide to bring romosozumab to patients and physicians who need additional treatment options for osteoporosis.”
Romosozumab was approved by the U.S. Food and Drug Administration (FDA) in April 2019 for the treatment of osteoporosis in postmenopausal women at high risk for fracture.5 Romosozumab is also approved in Japan6, and South Korea7, for the treatment of osteoporosis for women and men at high risk for fracture and in Canada8 for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
References
- Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 2016;375:1532-1543.
- Saag KG, Petersen, J, Brandiet ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 2017;377:1417–27.
- A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE). Available at: https://clinicaltrials.gov/ct2/show/NCT02186171?term=NCT02186171&rank=1. Accessed January 14, 2019.
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.
- EVENITY™ (romosozumab-aqqg) U.S. Prescribing Information https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx
- Pharmaceuticals and Medical Devices Agency Prescription Drug Database http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/112922_3999449G1025_1_02
- Ministry of Food and Drug Safety, Import Drug License. 20190531.
- Health Canada. Notice of Compliance, June 2017.
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.
About UCB
UCB, Brussels, Belgium (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 € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
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CONTACT: UCB, Brussels
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