FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

THOUSAND OAKS, Calif. and BRUSSELS, April 9, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has approved EVENITY™ (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider.² Since osteoporosis is a chronic disease, continued therapy with an anti-resorptive agent should be considered once EVENITY therapy is completed.

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"One in two women will experience a fracture due to osteoporosis in her lifetime.¹ These fractures can be devastating, with many leading to hospital stays and life-altering consequences.³ The FDA approval of EVENITY 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, chronic condition with no cure.^4,5 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.⁶ Osteoporosis-related fractures, known as bone breaks, are common, and the disease is responsible for an estimated two million fractures per year.⁶ After her first fracture, a woman is five times more likely to suffer another fracture within a year.⁷ 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.⁴ Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions.³ Given the aging population in the U.S., annual direct costs from osteoporosis are expected to reach approximately $25.3 billion by 2025.¹

"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. "EVENITY 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 EVENITY on the results of two Phase 3 studies. In the placebo-controlled FRAME study, treatment with EVENITY resulted in a significant reduction of new vertebral (spine) fracture at 12 months compared to placebo. This significant 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 significantly increased bone mineral density (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.

In the active-controlled ARCH study, treatment with EVENITY for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months. EVENITY followed by alendronate significantly 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 significantly 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 significantly increased BMD compared with alendronate alone.

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.²

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

This approval comes with a post-marketing requirement from the FDA to assess the cardiovascular safety of EVENITY 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.

"Women who experience a fracture due to osteoporosis are at significant risk for another fracture within one to two years;⁷ however, many of these patients are not diagnosed with osteoporosis as the underlying cause of fracture so they do not  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 EVENITY 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 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 treated,"^8,9 said Elizabeth Thompson, chief executive officer, National Osteoporosis Foundation. "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."

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 also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines through The Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage. 

EVENITY is expected to be available in approximately one week from select wholesalers in the U.S., at which time the price of EVENITY will be publicly available.

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 administered 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 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.⁸ Similarly, in the U.S. one in two women will fracture in her lifetime due to osteoporosis.¹ 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.⁸ 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

EVENITY™ 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

EVENITY™ may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY™ 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, EVENITY™ 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 EVENITY™ compared to those treated with alendronate.

Contraindications: EVENITY™ is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY™. EVENITY™ 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 EVENITY™-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY™.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY™. Correct hypocalcemia prior to initiating EVENITY™. 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 EVENITY™.  

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 EVENITY™. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY™. 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 EVENITY™ 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 EVENITY™. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY™ 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 EVENITY™ therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY™ were arthralgia and headache.

EVENITY™ is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see accompanying EVENITY™ 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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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kelley Davenport, 202-585-9637 (media)
Arvind Sood, 805-447-1060 (investors)

CONTACT: UCB, Brussels 
France Nivelle, Global Communications, UCB 
T +32.2.559.9178, [email protected] 
Laurent Schots, Media Relations, UCB 
T+32.2.559.92.64, [email protected]
Antje Witte, Investor Relations, UCB 
T +32.2.559.94.14, [email protected]
Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, [email protected] 

References

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

SOURCE Amgen

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