New osteoporosis medication has final approval in Europe
Treatment | Osteoporosis Management
19 Dec 2019
EVENITY® (romosozumab) has been approved in Europe, becoming the first new drug for osteoporosis in the area since 2010.
The medication’s approval by the European Commission allows clinicians to prescribe it for postmenopausal women with severe osteoporosis who are at high risk of breaking a bone and 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 the medicine appeared to increase the risk of heart and circulatory problems.
Following an appeal, the EMA granted a marketing authorisation for EVENITY® in October and the medication has now received final approval by the European Commission.
Half of women over the age of 50 are expected to break a bone due to osteoporosis, so European approval of the medicine is seen as a positive development that provides healthcare professionals and patients with improved choice in clinically effective osteoporosis treatments.
“Fragility fractures can often be avoided but their prevention and management are being neglected despite a large personal, societal and economic impact," says Alison Doyle, head of operations and clinical practice for the Royal Osteoporosis Society.
“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.
“Therefore, we welcome this approval as it represents a new therapeutic option for both patients and healthcare professionals in addressing this neglected condition," she adds.
The first launches of the medication in the European Economic Area are reportedly planned for the first half of 2020.