New osteoporosis medication approved for use in the UK

The European Medicines Agency (EMA) has decided to recommend EVENITY® (romosozumab), a new osteoporosis medicine, to treat postmenopausal women at high risk of breaking a bone who have no history of myocardial infarction or stroke.

Marketed by UCB and Amgen, EVENITY® was approved for use in the US by the Food and Drug Administration (FDA) in April this year after safety and efficacy data from two clinical trials, involving more than 11,000 women with postmenopausal osteoporosis, showed that it could lower the risk of a new spinal fracture by 73%.

Despite this, the medication was initially denied approval for use in the UK by the EMA’s Committee for Medicinal Products for Human Use (CHMP), over concerns that it was unclear why the medicine appeared to increase the risk of heart and circulatory problems.

Following an appeal, the EMA has now granted a marketing authorisation for EVENITY®, saying, “The Agency took into account the views of experts that restricting the use of the medicine to women who had no history of heart attack and stroke would reduce the risks of the latter problems occurring.

"Therefore, the Agency finally concluded that if restricted in this way the benefits of Evenity would outweigh its risks in postmenopausal women with severe osteoporosis who are at a high risk of fracture. Additional measures and studies are foreseen to follow its use in practice and to ensure that the medicine is used correctly.”

Given that osteoporosis is a chronic condition with no cure, that will cause one in two women to experience a fracture in her lifetime, UK approval of the medicine is seen as a positive development, providing healthcare professionals and patients with improved choice in clinically effective osteoporosis treatments.

Alison Doyle, head of operations and clinical practice at the Royal Osteoporosis Society, says: “One in two women will experience a broken bone in their lifetime due to osteoporosis. For the worst affected, this can result in debilitating spinal fractures, hospital stays and a dramatic reduction in quality of their life, so we very much welcome the approval of a highly effective drug which can be used to treat postmenopausal women who are at high risk of breaking a bone.”

She adds, “As with any medication, there are side effects that need to be considered and romosozumab may not be suitable for everyone. However, it is an innovative and highly effective drug that will benefit many people and provides improved patient choice. This is a very positive development, particularly since there are no other new osteoporosis medications currently in development.”

She adds, “Drugs aren’t the only solution though. We also need to better understand the causes of osteoporosis, which is why our Osteoporosis and Bone Research Academy is working with patients, research clinicians and academics in the field to advance our knowledge and ultimately find a cure for osteoporosis.”

The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A final decision is expected by year-end 2019.

David M Reese, MD, executive vice president of research and development at Amgen said, “We are pleased by the committee’s opinion, which brings romosozumab one step closer to becoming a new osteoporosis treatment option for patients with severe osteoporosis at high risk of fracture in Europe.”