MISSISSAUGA, ON, Oct. 8, 2019 /CNW/ - Today Amgen Canada announced that EVENITY® (romosozumab) is now available in Canada 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.
"We are pleased with Health Canada's decision to approve EVENITY and allow patients access to a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures," says Ponda Motsepe-Ditshego, Executive Medical Director at Amgen Canada. "Two million Canadians are affected by osteoporosis,2 and this approval provides a new option for physicians when treating patients who may be at risk."
Osteoporosis is a serious, chronic condition with no cure.3 According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide. In Canada the disease is responsible for over 80 per cent of all fractures in people over 50.2 After the initial fractures, one in two hip fracture patients in Canada will suffer another fracture within five years.2 Fewer than 20 per cent of fracture patients in Canada currently undergo diagnosis or adequate treatment for the disease.2
"Despite advances over the past few decades, many Canadian patients are still not being diagnosed and treated for osteoporosis," said Dr. Rick Adachi, Professor of Medicine at the Michael DeGroote School of Medicine at McMaster University, Hamilton, Ontario, Canada. "With the approval of EVENITY, physicians and their patients now have another proven treatment option to reduce the risk of these life-altering fractures."
"Osteoporosis is a major health burden, impacting more than two million people across Canada, and the availability of EVENITY puts us one step closer to decreasing the rates of debilitating osteoporotic fractures," said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada.
The Canadian approval of EVENITY was based on the results of two Phase 3 studies that demonstrated a reduction of new vertebral (spine) fractures and increased bone mineral density (BMD).
EVENITY is a bone formation 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 loss. The EVENITY development program includes 19 clinical studies that enrolled more than 14,000 patients globally. 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.
Important Safety Information1
EVENITY is contraindicated in patients who are hypersensitive to romosozumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
EVENITY is contraindicated in patients with hypocalcemia. Correct pre-existing hypocalcemia prior to initiating treatment with EVENITY.
The overall safety of EVENITY was studied in 19 clinical trials involving over 14,000 patients, with the Phase 3 program consisting of nearly 12,000 patients.
EVENITY has a Serious Warnings and Precautions Box in its product label which advises that EVENITY may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. EVENITY is not recommended in patients who have had a heart attack or stroke. Consider whether the benefits outweigh the risks in patients with other cardiovascular or cerebrovascular disease or associated risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.
More information on Adverse Reactions may be found in the EVENITY Product Monograph.
About the Pivotal EVENITY Clinical Trials
FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study (Study 1) that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the efficacy of EVENITY treatment (210 mg administered monthly), compared with placebo and showed a reduction of new vertebral (spine) fractures at 12 months compared to placebo. This reduction in fracture risk persisted through the second year in women who received EVENITY during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab. In addition, EVENITY increased BMD at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from EVENITY to denosumab at month 12, BMD continued to increase through month 24.4
ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) is a randomized, double-blind, alendronate-controlled study (Study 2) of EVENITY in 4,093 postmenopausal women with osteoporosis and previous fracture history. This event-driven study evaluated 12 months of EVENITY treatment (210 mg administered monthly) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone and showed a reduced incidence of new vertebral fracture at 24 months. EVENITY followed by alendronate reduced the risk of clinical fracture (defined as a composite of symptomatic vertebral fracture and nonvertebral fracture) after a median follow-up of 33 months. EVENITY increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate. Twelve months of treatment with EVENITY followed by 12 months of treatment with alendronate increased BMD compared with alendronate alone.5
Osteoporosis is a condition that causes bones to become thin and porous, decreasing bone strength and leading to increased risk of breaking a bone.2 The most common sites of broken bones from osteoporosis are the wrist, spine, shoulder and hip.2 Osteoporosis can strike at any age, however it mainly affects women after menopause as their ability to form new bone cannot counterbalance the rate at which bone is being resorbed.2,3 This bone loss leads to weakened bones over time, increasing the potential for a break.2
At least one in three women and one in five men will suffer a broken bone from osteoporosis during their lifetime.2 Broken bones from osteoporosis are more common than heart attack, stroke and breast cancer combined.2 One in three people who break a hip will re-break it at one year, and over one in two will suffer another bone break within five years.2
The World Health Organization has officially declared osteoporosis a public health crisis6, while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.7
About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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 metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.
Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.
- EVENITY™ Product Monograph. Amgen Canada Inc. (June 2019).
- Osteoporosis Canada. Osteoporosis Facts and Statistics. https://osteoporosis.ca/about-the-disease/fast-facts/ Accessed June 19, 2019.
- 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. Accessed June 19, 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 June 5, 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 June 5, 2019.
- The World Health Organization. Bulletin of the World Health Organization. Exercise interventions: defusing the world's osteoporosis time bomb. Available at: http://www.who.int/bulletin/volumes/81/11/mingchanwa1103.pdf. Accessed April 2019.
- International Osteoporosis Foundation. Global Initiatives. Available at http://www.iofbonehealth.org/global-initiatives-0. Accessed April 2019.
SOURCE Amgen Canada
For further information: Natasha Bond, Amgen Canada, Ph: 905-285-3007, email@example.com