FDA Approves Evenity™ (Romosozumab) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

Belgium BRUSSELS (April 9, 2019) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EVENITY™ (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. In the U.S., EVENITY is the first and only bone builder with a dual effect that both increases bone formation and, to a lesser extent, reduces bone resorption (or bone loss) to reduce the risk of fracture. A full course of romosozumab therapy is 12 once monthly doses administered, in the U.S., by a healthcare provider.1 Since osteoporosis is a chronic condition, continued therapy with an anti-resorptive agent should be considered once romosozumab therapy is completed.

“Women who experience a fracture due to osteoporosis are at significant risk for another fracture within one to two years;2 however, many of these patients are not diagnosed with osteoporosis as the underlying cause of the fracture so they do not always receive the proper care, and as a result, may experience new fractures,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We are excited that romosozumab is now approved in the U.S. and that physicians will have a new treatment option for postmenopausal women with osteoporosis who are at high risk for fracture.”
 
Osteoporosis is a serious, chronic condition with no cure.3,4 According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide. In the U.S. alone, 10 million Americans suffer from osteoporosis.5 Osteoporosis-related fractures, known as bone breaks, are common, and the condition is responsible for an estimated two million fractures per year.5 After her first fracture, a woman is five times more likely to suffer another fracture within a year.2 In fact, her fracture risk remains elevated over time if left untreated. Fractures for postmenopausal women can be life-altering events which can lead to loss of mobility.3 Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions.6 Given the aging population in the U.S., annual direct costs from osteoporosis are expected to reach approximately $25.3 billion by 2025.7
 
“After spending 30 years caring for women with osteoporosis and in clinical research, I know that women at high risk of fracture need another therapy that reduces fractures quickly,” said Felicia Cosman, M.D., professor of medicine at Columbia University College of Physicians and Surgeons in New York, co-editor in chief of the journal Osteoporosis International and principal investigator of the FRAME trial. “Romosozumab acts by a novel mechanism of action to reduce the risk of new vertebral fracture within 12 months, and it produces rapid and dramatic improvements in bone mass. These benefits are sustained upon transition to an anti-resorptive medication and address a critical need for patients at high risk of fracture.”
 
The FDA based its approval of romosozumab on the results of two Phase 3 studies; FRAME, a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture and ARCH, an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis who had a prior fracture. 
 
In the U.S., romosozumab has a Boxed Warning in its product label which advises that romosozumab may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. Romosozumab should not be initiated in patients who have had a heart attack or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a heart attack or stroke during therapy, romosozumab should be discontinued.1
 
This approval comes with a post-marketing requirement from the FDA to assess the cardiovascular safety of romosozumab in postmenopausal osteoporosis women. The requirement includes a five-year observational feasibility study, potentially followed by a comparative safety study or trial. Amgen is committed to the safety of patients and will continue to monitor all safety data as it emerges.
 
“One in two women will experience a fracture due to osteoporosis in her lifetime.7 These fractures can be devastating, with many leading to hospital stays and life-altering consequences.6 The FDA approval of romosozumab represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Postmenopausal osteoporosis is a significant women’s health issue that far too often gets overlooked. As a leader in bone health with more than 20 years of osteoporosis research experience, Amgen is as committed as ever to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture.”
 
“Osteoporosis is a serious disease that is underdiagnosed and often goes untreated. In fact, approximately 80 percent of patients who have had one or more osteoporotic-related fractures are not being identified or treated8,9,” said Elizabeth Thompson, chief executive officer of the National Osteoporosis Foundation in the U.S. “This approval is great news for patients and physicians because it gives them another much needed treatment option to help reduce the risk of life changing fractures.”
 
About EVENITY™ (romosozumab)
EVENITY is a bone-building humanized 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 more than 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 12,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
 
U.S. EVENITY Indication
EVENITYTM is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
 
The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. 
 
U.S. EVENITY Important Safety Information
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH
 
EVENITYTM may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITYTM should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITYTM should be discontinued.
 
In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITYTM compared to those treated with control.
 
Contraindications: EVENITYTM is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITYTM. EVENITYTM is contraindicated in patients with a history of systemic hypersensitivity to romosozumab-aqqg or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.
 
Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITYTM-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITYTM.
 
Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITYTM. Correct hypocalcemia prior to initiating EVENITYTM. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITYTM.  
 
Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITYTM. A routine oral exam should be performed by the prescriber prior to initiation of EVENITYTM. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy. 
 
For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITYTM should be considered based on benefit-risk assessment.
 
Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITYTM. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated. 
 
During EVENITYTM treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITYTM therapy should be considered based on benefit-risk assessment.
 
Adverse Reactions: The most common adverse reactions (≥ 10%) reported with EVENITYTM were arthralgia and back pain.
EVENITYTM is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity. 
Please see accompanying EVENITYTM full Prescribing Information, including Boxed Warning and Medication Guide.
 
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
 
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UCB Forward-Looking Statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
 
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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.
 
CONTACT: UCB, Brussels  
France Nivelle, Global Communications, UCB  
T +32.2.559.9178, france.nivelle@ucb.com  
 
Laurent Schots, Media Relations, UCB  
T+32.2.559.92.64, laurent.schots@ucb.com
 
Antje Witte, Investor Relations, UCB  
T +32.2.559.94.14, antje.witte@ucb.com
 
Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com  
 
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media) 
 
Kelley Davenport, 202-585-9637 (media)
 
Arvind Sood, 805-447-1060 (investors)
 
References
  1. EVENITY™ (romosozumab-aqqg) U.S. Prescribing Information 
  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. International Osteoporosis Foundation. The Global Burden of Osteoporosis: A Factsheet. Available at: https://iofbonehealth.org/sites/default/files/media/PDFs/Fact%20Sheets/2014-factsheet-osteoporosis-A4.pdf. March 26, 2019.
  4. National Osteoporosis Foundation. Treatment. Available at: http://nof.org/live/treating.  Accessed March 26, 2019.
  5. Dempster. Osteoporosis and the Burden of Osteoporosis-Related Fractures. AJMC. 2011.
  6. Cosman, et al. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25:2359–2381.
  7. National Osteoporosis Foundation. Osteoporosis Fast Facts. https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed February 11, 2019.
  8. International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics. Accessed March 26, 2019.
  9. Nguyen, T. V., Center, J. R., & Eisman, J. A. (2004). Osteoporosis: underrated, underdiagnosed and undertreated. The Medical Journal of Australia. 180;18-22.

 

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