The European Medicines Agency (EMA) has reversed a decision not to approve the monoclonal antibody Evenity (romosozumab) for the treatment of post-menopausal women with osteoporosis.
The agency adopted a negative opinion for Evenity in June due to safety concerns. However, after “re-examination”, a positive opinion for a restricted indication has been granted.
The agency was originally concerned about the results of clinical trials which suggested Evenity was associated with an increased risk of adverse cardiovascular events. As the underlying mechanism was unclear and there was no obvious group of patients in whom the risk was lower, the EMA was concerned that measures to reduce the risk could not readily be put in place.
During the re-examination, further analyses of the data were carried out and it was noted that the medicine appeared to show convincing evidence of benefit in women with severe osteoporosis, with long-lasting effects that appeared better than alendronate.
The EMA also took into account expert opinions that restricting use to women with no history of heart attack or stroke would reduce the risks of cardiovascular events. Hence, it granted Evenity a positive opinion for use in post-menopausal women with severe osteoporosis who are at a high risk of fracture.