UCB and Amgen Receive Positive Vote From FDA Advisory Committee In Favor of Approval For EVENITY™ (Romosozumab)
- Potential New Treatment Option for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Brussels, Belgium and Thousand Oaks, Calif. (January 16, 2019) - UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITY™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the pivotal Phase 3 studies. Eighteen of nineteen members voted yes for approval. In their discussion, the Committee emphasized the need for post-marketing follow-up.
“Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis.1 This is why new treatment options are so important,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “The Committee’s recommendation represents a step forward for patients and we look forward to working with our partner Amgen in the coming months to bring romosozumab to the patients that need it most.”
The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients.2 Notable Phase 3 studies include: FRAME,3 a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH,4 an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; and STRUCTURE, an active-comparator-controlled study with 436 postmenopausal women with osteoporosis.5 The BRUDAC evaluated the FRAME and ARCH studies in its review of the clinical benefit:risk profile of romosozumab, including the cardiovascular safety finding seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.
“We are pleased with the Committee’s recommendation to approve romosozumab for the treatment of postmenopausal women with osteoporosis at high risk for fracture,” said David M. Reese, M.D., Executive Vice President of Research and Development at Amgen. “A fracture due to osteoporosis can be devastating to the lives of patients. After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated.6 Despite available therapies, these women who are at high risk for fracture could benefit from an additional treatment option that has the potential to build new bone and slow existing bone loss. We are committed to working with the FDA to help make romosozumab available to appropriate patients.”
While the FDA is not bound by the Advisory Committee's recommendations, it takes the advice into consideration when making its decision.
In the U.S., one in two women over the age of 50 will experience an osteoporotic fracture.7 Unfortunately, only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post-fracture.1
Romosozumab was granted marketing authorization – its first approval anywhere in the world - by the Japanese Ministry of Health, Labour and Welfare on January 8, 2019 for the treatment of osteoporosis in patients at high risk of fracture.8 The European Medicines Agency (EMA) is currently reviewing a marketing application for romosozumab and interactions with the agency are ongoing.
- International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics. Accessed January 1, 2019.
- Amgen Briefing Information for the January 16, 2019 Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM629458.pdf. Accessed January 15, 2019
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. Accessed January 1, 2019.
- Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH). Available at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1. Accessed November 27, 2018.
- An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE). Available at: https://clinicaltrials.gov/ct2/show/NCT01796301?term=STRUCTURE+ROMOSOZUMAB&rank=1.
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323. Accessed January 1, 2019.
- National Osteoporosis Foundation. Osteoporosis Fast Facts. https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed January 1, 2019.
- Pharmaceuticals and Medical Devices Agency Prescription Drug Database http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/
About EVENITY (romosozumab)
Romosozumab is a bone-forming monoclonal antibody approved in Japan. It is designed to work by inhibiting the activity of sclerostin, which enables romosozumab to increase bone formation and reduce bone resorption. Romosozumab has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 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) 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 in immunology and neurology. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
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