Healthcare Industry News: U.S. Food and Drug Administration
News Release - January 8, 2019
EVENITY(TM) (romosozumab) Receives Approval In Japan For The Treatment Of Osteoporosis In Patients At High Risk Of FractureEVENITY Approved to Reduce the Risk of Fractures and Increase Bone Mineral Density in Men and Postmenopausal Women With Osteoporosis at High Risk of Fracture
EVENITY in Japan is Being Co-Developed Through a Strategic Alliance With Amgen Astellas BioPharma
THOUSAND OAKS, Calif. and BRUSSELS, Belgium, Jan. 8, 2019 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the Japanese Ministry of Health, Labor and Welfare has granted a marketing authorization for EVENITY™ (romosozumab) for the treatment of osteoporosis in patients at high risk of fracture.1 Amgen and UCB are co-developing EVENITY worldwide, with development in Japan being led by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.
"The approval of EVENITY in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment.2 With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."
EVENITY is a bone forming agent that both increases bone formation and reduces bone resorption to increase bone mineral density (BMD) and reduce the risk of fracture. The approval is based on results from two pivotal Phase 3 studies: FRAME,3 which included 7,180 postmenopausal women with osteoporosis, and BRIDGE,4 which included 245 men with osteoporosis. The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.
"In Japan, osteoporotic fracture is one of the leading causes for patients losing independence and needing nursing care. As the aged population of Japan increases, preventing such fractures should be given high priority," said Steve Sugino, Amgen vice president and president and representative director of AABP. "Japanese patients will be the first in the world to have a new therapeutic option for osteoporosis that reduces the risk of fracture by not only increasing bone formation but also decreasing bone resorption."1
"Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent," said Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university's Fujii Memorial Institute of Medical Sciences. "Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan."
Japan has one of the longest life expectancy rates in the world, and it is believed that by 2050, over 37 percent of the population will be aged 60 or older. 5 Age is one of the most common risk factors associated with developing osteoporosis, as bone mass is lost over time.6,7 Today, the prevalence of osteoporosis in the country is around 12 million, and the hip fracture incidence rate in the population over 75 is increasing dramatically in both men and women.8
"With one of the longest life expectancy rates in the world, Japan is a country of longevity, but this means that the rate of osteoporosis will increase, leaving many people at high risk for fracture due to the condition," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We are proud that EVENITY is now approved as a new treatment to help address this important public health issue and help people with their osteoporosis."
This is the first approval for EVENITY in the world, and the third approval of a new medicine through AABP.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing.
About the Pivotal EVENITY Clinical Trials
FRAME (FRActure Study In Postmenopausal WoMen With OstEoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the effectiveness of EVENITY treatment (210 mg), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months.
ARCH (Active-ContRolled FraCture Study In Postmenopausal Women With Osteoporosis At High Risk Of Fracture) is a randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment (210 mg) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to determine effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.
BRIDGE (PlaceBo-ContRolled Study EvaluatIng The Efficacy AnD Safety Of Romosozumab In TreatinG MEn With Osteoporosis) is a randomized, double-blind, placebo-controlled study of 245 men aged 55-90 years with osteoporosis and a history of fragility fracture (excluding hip fracture) or vertebral fracture. The study evaluated the effectiveness of EVENITY treatment for 12 months, compared with placebo, in increasing BMD at the lumbar spine and the effect on BMD at the femoral neck and total hip.
About Fragility Fractures
Worldwide, one in three women and one in five men, over the age of 50, will suffer a fragility fracture due to osteoporosis and with an aging population these numbers will rise.2 Yet despite this, we are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture.9 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
About EVENITY™ (romosozumab)
EVENITY is an bone-forming monoclonal antibody approved in Japan.. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to both rapidly increase bone formation and reduce bone resorption simultaneously. EVENITY 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 EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
Important Japan Product Information
EVENITY® subcutaneous injection 105mg syringe
Romosozumab (Genetical Recombination) Injection
Osteoporosis at high risk of fracture
Dosage and Administration:
The usual adult dosage is 210 mg as romosozumab (genetical recombination) by subcutaneous injection once a month for 12 months.
For more information, see the Japan Package Inserts.
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
About Amgen Astellas BioPharma K.K.
Amgen Astellas BioPharma K.K. (AABP) is a Japanese company that began operations on Oct. 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen, one of the world's leading independent biotechnology companies, and Astellas Pharma Inc., a leading Tokyo-based R&D oriented global pharmaceutical company.
AABP has grown into an organization with over 400 employees and comprehensive functions to be fully operational as a marketing authorization holder in Japan. AABP's sales organization, with 19 regional sales offices located throughout Japan, will co-promote its products with Astellas. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020.
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 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
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
*The trade name EVENITY™ is provisionally approved for use by the FDA and EMA.
1. Pharmaceuticals and Medical Devices Agency Prescription Drug Database http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/
2. International Osteoporosis Foundation. Patient Brochure. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf. Accessed December 6, 2018.
3. 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 November 2018.
4. 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 November 2018, 2016.
5. Population projections for Japan, 2001-2050, The National Institute of Population and Social Security Research, 2002.
6. Kanis JA, Johnell O, Odén A, Dawson A, De LAet C, Jonsson B. Ten year probabilities of osteoporotic fractures according to BMD and diagnosis thresholds. Osteoporosis Int 2001;12:989-95
7. International Osteoporosis Foundation. Fixed Risk Factors. Available at http://www.iofbonehealth.org/fixed-risk-factors. Accessed November 2018
8. International Osteoporosis Foundation. Asian_regional_audit_Japan. Available at: https://www.iofbonehealth.org/sites/default/files/PDFs/Audit%20Asia/Asian_regional_audit_Japan.pdf. Accessed November 2018.
9. International Osteoporosis Foundation. Facts and Statistics. Available at https://www.iofbonehealth.org/facts-statistics. Accessed December 17, 2018.
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