Amgen and UCB Announce FDA Approval of EVENITY (romosozumab-aqqg) for High-Risk Postmenopausal Osteoporosis

VCBeat (WeChat Official Account: vcbeat) has learned that on April 10, Amgen and UCB (UCB Pharma) announced that the FDA approved EVENITY (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

Osteoporosis is a serious chronic disease that is incurable. According to data from the World Health Organization, osteoporosis represents a major public health crisis affecting millions of people worldwide. In the United States alone, 10 million Americans suffer from osteoporosis. Osteoporosis-related fractures are common, with an estimated 2 million fractures caused by the condition each year. Within one year of an initial fracture, women are five times more likely than men to experience a subsequent fracture. Without timely treatment, the frequency of fractures in patients tends to increase over time. By 2025, the annual direct costs associated with osteoporosis and related conditions in the United States are projected to reach approximately $25.3 billion. Currently, particularly in post-fracture scenarios, it is estimated that four out of five patients remain undiagnosed and untreated after experiencing a fracture. Without appropriate care or access to effective interventions, these individuals face the risk of painful and disabling fractures in the future.

EVENITY is a bone-building humanized monoclonal antibody and the only novel anabolic agent with a unique dual mechanism of action. EVENITY works by inhibiting the activity of sclerostin, thereby promoting bone formation while, to a lesser extent, reducing bone resorption (or bone loss), which rapidly lowers the risk of fractures. The efficacy of EVENITY was confirmed in two active-controlled clinical trials involving a total of nearly 10,000 postmenopausal women with osteoporosis.

EVENITY is indicated for the treatment of postmenopausal women at high risk of fracture, or for patients who are ineffective or intolerant to other osteoporosis therapies. EVENITY is a prescription medication, with a treatment course of 12 months. After 12 months, the anabolic effect of EVENITY diminishes. Therefore, the duration of EVENITY use should be limited to 12 months. As osteoporosis is a chronic disease that cannot be cured, patients should consider continuing treatment with anti-resorptive agents.

The most common adverse reactions to EVENITY are arthralgia and headache. Additionally, the EVENITY product labeling includes a Boxed Warning: EVENITY may increase the risk of myocardial infarction (heart attack), stroke, and cardiovascular death. The benefits and risks of EVENITY should be carefully considered before initiating treatment in patients who have had a heart attack or stroke within the preceding year. If a patient experiences a heart attack or stroke during treatment, EVENITY should be discontinued immediately.

Dr. Pascale Richetta, Executive Vice President of UCB, stated, “The approval of EVENITY is welcome news for both patients and physicians, offering a new treatment option for postmenopausal women with osteoporosis.”

David M. Reese, Executive Vice President of Research and Development at Amgen, stated, “Postmenopausal osteoporosis is a significant women’s health issue that is often overlooked. As a leader in bone health, Amgen has over 20 years of experience in osteoporosis research and remains committed to combating this disease, helping women at high risk of fractures reduce their risk of both initial and subsequent fractures.”

Notably, since 2004, Amgen and UCB have collaborated under a collaboration and license agreement to research, develop, and commercialize antibody products targeting sclerostin. As part of this agreement, the two companies will continue to jointly develop romosozumab for the treatment of osteoporosis.

Amgen is one of the world’s leading biotechnology companies, founded in 1980. Deeply rooted in science and innovation, the company transforms new ideas and discoveries into medicines for patients with serious illnesses. It offers products for the treatment of diseases in the fields of oncology, hematology, cardiovascular health, inflammation, bone health, nephrology, and neuroscience. Amgen focuses on areas with unmet medical needs and leverages its expertise in biologics to strive for solutions that can significantly improve people’s lives.

UCB is a biopharmaceutical and specialty chemicals company headquartered in Belgium, focusing on two therapeutic areas: central nervous system (CNS) disorders and immunology. In the CNS domain, the company addresses conditions such as epilepsy, diabetic neuropathic pain, multiple sclerosis, fibromyalgia, restless legs syndrome, and Parkinson’s disease. In immunology, it focuses on diseases including allergies, osteoporosis, Crohn’s disease, rheumatoid arthritis, and systemic lupus erythematosus. UCB and its subsidiaries operate research and development facilities in Belgium, Germany, Japan, the United Kingdom, and the United States.

(Compiled by Li Chengping)