CHMP reverses decision on romosozumab for osteoporosis
Following an initially negative opinion in June and subsequent re-examination of the data, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has reversed its decision on romosozumab (Evenity) for the treatment of osteoporosis in postmenopausal women, now recommending the granting of a marketing authorisation.
Romosozumab is a novel bone-building monoclonal antibody therapy that inhibits the activity of the signalling protein sclerostin, resulting in increased bone formation and, to a lesser extent, decreased bone resorption. It is administered by subcutaneous injection once monthly for a year. Romosozumab is already approved in several countries worldwide for use in women; in Japan, South Korea and Australia, it is also approved for the treatment of men with osteoporosis at high risk of fracture.
The efficacy of romosozumab was demonstrated in a series of phase 3 trials, including two pivotal trials comparing it with either placebo or the active comparator alendronate (a bisphosphonate) in over 11,000 postmenopausal women with osteoporosis, which showed that romosozumab can decrease the number of osteoporotic fractures (vertebral and non-vertebral) in postmenopausal women with severe osteoporosis at high risk of fractures.
The most common side-effects are nasopharyngitis and arthralgia. However, clinical trials have also indicated that romosozumab may increase the risk of serious cardiovascular events, including myocardial infarction and stroke. It was these safety concerns that prompted the initial negative opinion from the CHMP. The later positive opinion therefore recommended a more restricted indication: for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
A final decision on a marketing authorisation from the European Commission is expected by the end of the year.