European Commission Approves EVENITY[®] (Romosozumab) for the Treatment of Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture

Brussels, Belgium and Thousand Oaks, Calif (December 12, 2019) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Romosozumab is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption (or bone loss). 

“Today’s European population is living longer and expecting more out of life in their later years. Yet fragility fractures, due to osteoporosis, affect 1 in 3 women aged over 50, and evidence shows that many women remain undiagnosed and untreated following a fracture. These fractures represent a barrier to healthy aging, potentially impacting independence and quality of life,¹” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “With today’s approval of romosozumab we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.”

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in October 2019. The first launches of romosozumab in the European Economic Area (EEA) are planned for the first half of 2020.

As the population ages, the incidence and contribution of fragility fractures to the overall healthcare spend in Europe will continue to rise. Recent studies estimate that every year €37 billion is spent on healthcare costs for the 2.7 million fragility fractures that occur across the EU6 nations of France, Germany, Italy, Spain, Sweden, and the UK.¹ This annual expenditure is predicted to increase to over €47 billion by 2030.¹ 

“After her first fracture, a woman is five times more likely to suffer another fracture within a year.² Romosozumab is a significant step forward in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased by the European Commission’s approval to make this therapy available to the millions of women at high risk of fracture in the European Union.”

“Fragility fractures can often be avoided but their prevention and management are being neglected despite a large personal, societal and economic impact. With the number of worldwide fractures expected to rise there is a growing need to take action and prioritise post-fracture care through better education, specialist services, lifestyles and medicines,” said Alison Doyle, head of clinical operations for the Royal Osteoporosis Society. “Therefore, we welcome this approval as it represents a new therapeutic option for both patients and health care professionals in addressing this neglected condition.”

European Commission marketing authorization approval is valid in all European Union (EU) and EEA-European Free Trade Association (EFTA) states (Norway, Iceland, and Liechtenstein). Romosozumab is now approved in 37 countries, including the U.S., Japan, Canada and Australia.
 
References

1. International Osteoporosis Foundation. Broken Bones, Broken Lives: A Roadmap to Solve the Fragility Fracture Crisis in Europe. http://share.iofbonehealth.org/EU-6-Material/Reports/IOF%20Report_EU.pdf (November 2019).
2. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.

About EVENITY^® (romosozumab)
Romosozumab is a bone-forming 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 romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients. Romosozumab 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 romosozumab to either placebo or active comparator in over 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.

Important Safety Information about EVENITY^® (romosozumab) in the EU/EEA
In the EU, Romosozumab is indicated for treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Contraindications: Romosozumab is contraindicated in patients who are allergic to romosozumab or any of the excipients, who have low levels of calcium in the blood (hypocalcaemia), or who have a history of myocardial infarction (heart attack) or stroke. Myocardial infarction or stroke: Heart attack and stroke have been reported in patients receiving Romosozumab in randomised controlled trials (uncommon). Treatment with Romosozumab should not be initiated in patients with a history of heart attack or stroke. When determining whether to use Romosozumab for an individual patient, the presence of risk factors for cardiovascular problems, including established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking or kidney problems, should be evaluated. Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk. If a patient experiences a myocardial infarction or stroke during therapy, treatment with Romosozumab should be discontinued. Hypocalcaemia: Transient hypocalcaemia has been observed in patients receiving Romosozumab. Hypocalcaemia should be corrected prior to initiating therapy with Romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia. If any patient presents with suspected symptoms of hypocalcaemia during treatment, calcium levels should be measured. Patients should be adequately supplemented with calcium and vitamin D. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29ml/min/1.73m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients are limited. Calcium levels should be monitored in these patients. Hypersensitivity: Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the Romosozumab group in clinical trials. If an anaphylactic or other clinically significant allergic reaction occurs, appropriate therapy should be initiated and use of Romosozumab should be discontinued. Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) has been reported rarely in patients receiving Romosozumab. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: (1) potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of bone resorption therapy, (2) cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking, (3) concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck, (4) poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions. All patients should be encouraged to maintain good oral hygiene and receive routine dental check-ups. Dentures should fit correctly. Patients under dental treatment, or who will undergo dental surgery (e.g. tooth extractions) whilst being treated with Romosozumab should inform their doctor about their dental treatment and inform their dentist that they are receiving Romosozumab. Patients should immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or pus discharge during treatment with Romosozumab. Patients who are suspected of having or who develop ONJ while receiving Romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of Romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible. Atypical Femoral Fractures: Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving Romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of Romosozumab therapy should be considered, based on an individual benefit-risk assessment. Adverse Reactions: The most common adverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%). Common adverse reactions included hypersensitivity, sinusitis, rash, dermatitis, headache, neck pain, muscle spasms and injection site reactions (most frequent injection site reactions were pain and erythema). Uncommon adverse reactions were urticaria, hypocalcaemia, stroke, myocardial infarction and cataract. Finally, rare side effects were serious allergic reactions which caused swelling of the face, throat, hands, feet, ankles or lower legs (angioedema) and acute skin eruption (erythema multiforme).

Refer to the attached European Summary of Product Characteristics for other adverse reactions and full prescribing information for EVENITY^®▼.

▼ This medicinal product is subject to additional monitoring.
 
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.

CONTACT: UCB, Brussels
Scott Fleming, Bone Communications, UCB, T +44 7702777378, scott.fleming@ucb.com
Laurent Schots, Media Relations, UCB, T+32.2.559.92.64, laurent.schots@ucb.com
Antje Witte, Investor Relations, UCB, T +32.2.559.94.14, antje.witte@ucb.com
Isabelle Ghellynck, Investor Relations, UCB, T+32.2.559.9588, isabelle.ghellynck@ucb.com

CONTACT: Amgen, Thousand Oaks

Jessica Akopyan, 805-447-0974 (media) 
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

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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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. 

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