The European Medicines Agency (EMA) has refused a licence for romosozumab (Evenity) for the treatment of osteoporosis.
Although the drug was approved by the US Food and Drug Administration (FDA) earlier this year, the EMA said it was not convinced by the efficacy data and had safety concerns.
The agency considered data from three main studies involving over 11,000 post-menopausal women and 252 men with osteoporosis, comparing romosozumab with alendronate or placebo. The main measure of effectiveness in all the studies was the number of new vertebral fractures.
The EMA was concerned about the safety data, which demonstrated an increased risk of major cardiovascular events including myocardial infarction and stroke. When all the data were looked at together, there were more deaths in patients aged over 75 years given romosozumab.
While romosozumab was effective in reducing the risk of fracture in patients with severe osteoporosis, the benefit was not as convincing in patients with less severe disease, the EMA determined.
“Under the circumstances, the Agency’s opinion was that the benefits of Evenity did not outweigh its risks and it recommended refusing marketing authorisation,” the EMA said in a statement.