EVENITY™ (romosozumab Aqqg) Now Available In The United States For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

THOUSAND OAKS, Calif., April 15, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that EVENITY™ (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

"Osteoporosis is a silent disease that can lead to devastating consequences. Unfortunately, only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment post-fracture," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "This is unacceptable for the millions of women who have suffered from an osteoporosis-related fracture. We need to urgently make postmenopausal osteoporosis a women's health priority."

Osteoporosis is a serious, chronic condition with no cure.1,2 According to the World Health Organization, osteoporosis is a major public health crisis, affecting millions of people worldwide. In the U.S. alone, 10 million Americans suffer from osteoporosis.3 Osteoporosis-related fractures, known as bone breaks, are common, and the disease is responsible for an estimated two million fractures per year.3 After her first fracture, a woman is five times more likely to suffer another fracture within a year.4 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.1 Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions.5 Given the aging population in the U.S., annual direct costs from osteoporosis are expected to reach approximately $25.3 billion by 2025.6

"After experiencing two fractures in a short period of time, I became concerned and visited a specialist who diagnosed me with osteoporosis. I never realized that once I suffered a fracture, my risk became even greater for having another one. Osteoporosis has changed my life. I have curvature of my spine, and I am unable to stand, walk or sit without discomfort," said Judy M., a patient from Maryland with postmenopausal osteoporosis. "I'm very excited for a new treatment option for myself, as well as the thousands of other women who may benefit from a treatment that will build bone and slow bone loss."

The approval of EVENITY in the U.S. helps address an unmet need by providing another option for postmenopausal women at high risk for fracture who need to build bone rapidly within 12 months and to reduce the risk of a first or subsequent fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider.

EVENITY has a Boxed Warning in its product label, which advises that EVENITY may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. EVENITY 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, EVENITY should be discontinued.

The most common adverse reactions (≥ 5 percent) reported with EVENITY were arthralgia (joint pain) and headache.

"There are many patients that I see in clinical practice who make lasting impressions on me. One of those patients is Judy, and while her case may seem like an extreme example, I see far too many women who have similar stories," said Andrea Singer, M.D., internist and bone health specialist at MedStar Georgetown University Hospital in Washington, D.C., and Chief Medical Officer at the National Osteoporosis Foundation. "With the approval of EVENITY, we have a new treatment option in our tool chest to find the appropriate treatment for each individual based on her clinical risk factors, goals of treatment and individual preferences."

Amgen is committed to supporting the osteoporosis community and to helping appropriate patients with affordable access to EVENITY. The Amgen Assist® support program can help patients and physician offices navigate insurance coverage and identify access resources for patients. Amgen Assist can also refer patients as a courtesy to other potential resources such as Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen that can provide EVENITY at no cost to qualifying patients who have a financial need and are uninsured or whose insurance plan excludes coverage for EVENITY.

The price of EVENITY is in line with Amgen's focus on innovation and commitment to responsible pricing for patients in the U.S. and takes into consideration the physical and financial impact osteoporosis-related fractures can have on postmenopausal women and their families and caregivers. Amgen will make EVENITY available at a U.S. list price of $1,825 per dose, or $21,900 for a full course of treatment (12 monthly doses). This list price for a full course of therapy of EVENITY is 34 to 74 percent lower than currently available anabolic agents over their full course of therapy (daily doses for 18-24 months).

About EVENITY™ (romosozumab-aqqg)
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.

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 injection administered once monthly), compared with placebo, in reducing the incidence of new vertebral fractures through 12 months. The study also evaluated the efficacy of treating with EVENITY for 12 months followed by denosumab (60 mg injection every six months) for 12 months, compared with placebo followed by denosumab, in reducing the incidence 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 (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, to assess its efficacy in reducing the risk of clinical fracture (non-vertebral fracture and symptomatic vertebral fracture) through the primary analysis period and the incidence of new vertebral fracture at 24 months.

About Osteoporosis-related Fractures
Worldwide, one in three women and one in five men, over the age of 50, will suffer a  fracture due to osteoporosis.Similarly, in the U.S. one in two women will fracture in her lifetime due to osteoporosis.6 With an aging population these numbers will rise, 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.7 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.

Important U.S. Product Information

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.

Important U.S. 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 alendronate.

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 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 (≥ 5%) reported with EVENITYTM were arthralgia and headache.

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.

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.

CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Jessica Akopyan, 805-447-0974 (media)
Arvind Sood, 805-447-1060 (investors)

References

  1. 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.
  2. National Osteoporosis Foundation. Treatment. Available at: http://nof.org/live/treating.  Accessed March 26, 2019.
  3. Dempster. Osteoporosis and the Burden of Osteoporosis-Related Fractures. AJMC. 2011.
  4. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.
  5. Cosman, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25:2359–2381.
  6. National Osteoporosis Foundation. Osteoporosis Fast Facts. https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed February 11, 2019.
  7. International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics. Accessed March 26, 2019.

SOURCE Amgen

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