First New Osteoporosis Medicine Approved in the European Union (EU) Since 2010
Novel Bone-Builder With a Dual Effect That Increases Bone Formation and Reduces Bone Loss
THOUSAND OAKS, CA, USA and BRUSSELS, Belgium I December 11, 2019 I Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. EVENITY is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption (or bone loss).
“After her first fracture, a woman is five times more likely to suffer another fracture within a year.1 EVENITY is a significant step forward in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased by the European Commission’s approval to make this therapy available to the millions of women at high risk of fracture in the European Union.”
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in October 2019. The first launches of EVENITY in the European Economic Area (EEA) are planned for first half of 2020.
As the population ages, the incidence and contribution of fragility fractures to the overall healthcare spend in Europe will continue to rise. Recent studies estimate that every year €37 billion is spent on healthcare costs for the 2.7 million fragility fractures that occur across France, Germany, Italy, Spain, Sweden and the UK.2 This annual expenditure is predicted to increase to over €47 billion by 2030.2
“Today’s European population is living longer and expecting more out of life in their later years. Yet fragility fractures due to osteoporosis affect one in three women aged over 50, and evidence shows that many women remain undiagnosed and untreated following a fracture. These fractures represent a barrier to healthy aging, potentially impacting independence and quality of life2,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “With today’s approval of EVENITY we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.”
“Fragility fractures can often be avoided, but their prevention and management are being neglected despite a large personal, societal and economic impact. With the number of worldwide fractures expected to rise there is a growing need to take action and prioritize post-fracture care through better education, specialist services, lifestyles and medicines,” said Alison Doyle, head of clinical operations for the Royal Osteoporosis Society. “Therefore, we welcome this approval as it represents a new, therapeutic option for both patients and health care professionals in addressing this neglected condition.”
European Commission marketing authorization approval is valid in all EU and EEA-European Free Trade Association (EFTA) states (Norway, Iceland and Liechtenstein). EVENITY is now approved in 37 countries, including the U.S., Japan, Canada and Australia.
About EVENITY® (romosozumab)
EVENITY 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 EVENITY 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 EVENITY to either placebo or active comparator in nearly 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
About Osteoporosis-Related 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.3 Yet despite this, there is 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.4 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
Important EU/EEA Product Information
EVENITY® (romosozumab) is indicated for treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
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 Amgen
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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.
References
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.
- International Osteoporosis Foundation. Broken Bones, Broken Lives: A Roadmap to Solve the Fragility Fracture Crisis in Europe. http://share.iofbonehealth.org/EU-6-Material/Reports/IOF%20Report_EU.pdf Accessed November 18, 2019.
- International Osteoporosis Foundation. Patient Brochure. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf. Accessed November 18, 2019.
- Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis: underrated, underdiagnosed and undertreated. Med J Aust 180:S18.
- EVENITY™ (romosozumab-aqqg) U.S. Prescribing Information https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx
SOURCE: Amgen
Post Views: 144
First New Osteoporosis Medicine Approved in the European Union (EU) Since 2010
Novel Bone-Builder With a Dual Effect That Increases Bone Formation and Reduces Bone Loss
THOUSAND OAKS, CA, USA and BRUSSELS, Belgium I December 11, 2019 I Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. EVENITY is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption (or bone loss).
“After her first fracture, a woman is five times more likely to suffer another fracture within a year.1 EVENITY is a significant step forward in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased by the European Commission’s approval to make this therapy available to the millions of women at high risk of fracture in the European Union.”
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in October 2019. The first launches of EVENITY in the European Economic Area (EEA) are planned for first half of 2020.
As the population ages, the incidence and contribution of fragility fractures to the overall healthcare spend in Europe will continue to rise. Recent studies estimate that every year €37 billion is spent on healthcare costs for the 2.7 million fragility fractures that occur across France, Germany, Italy, Spain, Sweden and the UK.2 This annual expenditure is predicted to increase to over €47 billion by 2030.2
“Today’s European population is living longer and expecting more out of life in their later years. Yet fragility fractures due to osteoporosis affect one in three women aged over 50, and evidence shows that many women remain undiagnosed and untreated following a fracture. These fractures represent a barrier to healthy aging, potentially impacting independence and quality of life2,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “With today’s approval of EVENITY we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.”
“Fragility fractures can often be avoided, but their prevention and management are being neglected despite a large personal, societal and economic impact. With the number of worldwide fractures expected to rise there is a growing need to take action and prioritize post-fracture care through better education, specialist services, lifestyles and medicines,” said Alison Doyle, head of clinical operations for the Royal Osteoporosis Society. “Therefore, we welcome this approval as it represents a new, therapeutic option for both patients and health care professionals in addressing this neglected condition.”
European Commission marketing authorization approval is valid in all EU and EEA-European Free Trade Association (EFTA) states (Norway, Iceland and Liechtenstein). EVENITY is now approved in 37 countries, including the U.S., Japan, Canada and Australia.
About EVENITY® (romosozumab)
EVENITY 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 EVENITY 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 EVENITY to either placebo or active comparator in nearly 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
About Osteoporosis-Related 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.3 Yet despite this, there is 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.4 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
Important EU/EEA Product Information
EVENITY® (romosozumab) is indicated for treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
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 Amgen
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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.
References
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.
- International Osteoporosis Foundation. Broken Bones, Broken Lives: A Roadmap to Solve the Fragility Fracture Crisis in Europe. http://share.iofbonehealth.org/EU-6-Material/Reports/IOF%20Report_EU.pdf Accessed November 18, 2019.
- International Osteoporosis Foundation. Patient Brochure. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf. Accessed November 18, 2019.
- Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis: underrated, underdiagnosed and undertreated. Med J Aust 180:S18.
- EVENITY™ (romosozumab-aqqg) U.S. Prescribing Information https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx
SOURCE: Amgen
Post Views: 144
