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NINE DRUG FORMULARIES IN CANADA LIST EVENITY FOR REIMBURSEMENT FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AT HIGH RISK OF FRACTURE | ||||||||||||||||||||||||||||||||||||
By: PR Newswire Association LLC. - 05 Mar 2024 | Back to overview list |
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Multiple formulary listings are a step forward to ensuring that postmenopausal women have access to medicines that address the unmet medical needs associated with osteoporosis MISSISSAUGA, ON, March 5, 2024 /CNW/ - Amgen Canada announced today that EVENITY® (romosozumab) has been listed for reimbursement on ten of Canada's public formularies. With this announcement most postmenopausal women in Canada will be able to access this biologic treatment. EVENITY received Health Canada approval in 2019 and 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.1 Patients in Ontario2, British Columbia3, Saskatchewan4, New Brunswick5, Nova Scotia6, Newfoundland & Labrador7, and patients covered by Veterans Affairs Canada8 and NIHB9, now have access to reimbursement of EVENITY for the treatment of osteoporosis in postmenopausal women who have a history of osteoporotic fracture, are at high risk for future fracture (defined as a 10-year fracture risk of ?20% as defined by the FRAX tool), are treatment naive to osteoporosis medications and are not receiving concurrent osteoporosis medications, except for calcium and/or vitamin D. In Quebec10, EVENITY is now reimbursed for the treatment of osteoporosis in menopausal women exposed to a high risk of fracture defined by a history of fragility fracture at the hip or vertebral column or a very high risk of fracture defined by the presence of a new fragility fracture at the hip or vertebral column in the last 24 months, or by a history of more than one fragility fracture at the vertebral column. Osteoporosis is a chronic, age-related disease which causes fractures that have costly human and socio-economic consequences.11 In Canada the disease is responsible for over 80 per cent of all fractures in people over 50.12 After the initial fractures, one in three hip fracture patients in Canada will suffer another fracture within a year.12 According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide.13 Fewer than 20 per cent of fracture patients in Canada currently undergo diagnosis or adequate treatment for the disease.12 "We are pleased to see so many formularies allow patients access to a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures14 ," says Dr. Daniel Martinez, Executive Medical Director at Amgen Canada. "Over Two million Canadians are affected by osteoporosis,11 and this approval provides a new option for physicians when treating patients who may be at risk." "Although many provinces have provided some coverage for bone preserving therapies for years, the fact is that bone forming therapies are optimal for patients with severe osteoporosis. Formulary availability for EVENITY, a bone forming treatment, in many provinces—followed by maintenance care on bone preserving medications—represents an important advance in care for osteoporosis patients at highest risk of disabling fragility fractures," said Dr. David Kendler, Clinical Professor in the Division of Endocrinology at the University of British Columbia, Director of the Osteoporosis Program at ProHealth in Vancouver, BC. "Osteoporosis is a major health burden, impacting more than two million people12 across Canada, and the accessibility of EVENITY puts us one step closer to decreasing the rates of debilitating osteoporotic fractures," said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada. About EVENITY®1 Important Safety Information1 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 Osteoporosis12 At least one in three women and one in five men will suffer a broken bone from osteoporosis during their lifetime. Broken bones from osteoporosis are more common than heart attack, stroke and breast cancer combined. 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. According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide13 while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.15 About Amgen Canada Amgen Forward-Looking Statements 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.
SOURCE Amgen Canada |
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