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European Medicines Agency rejects osteoporosis medication romosozumab

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The European Medicines Agency rejected the marketing authorization of the osteoporosis drug romosozumab, according to a press release from Amgen and UCB, citing potential cardiovascular risks as a major determining factor.

In a release of its own, the European Medicines Agency (EMA) stated that due to some evidence that romosozumab (Evenity) makes myocardial infarctions and strokes more likely to occur while also potentially increasing mortality risk in older adults, the agency could not fully endorse marketing of the osteoporosis medication.

“As it was unclear why the medicine appeared to increase the risk of heart and circulatory problems, and there was no obvious group of patients in whom the risk of these was lower, measures to reduce the risk could not readily be put in place,” the release stated. “Under the circumstances, the agency’s opinion was that the benefits of Evenity did not outweigh its risks, and it recommended refusing marketing authorization.”

Romosozumab has cleared regulatory hurdles in several other regions, including gaining approval from the FDA in April as well as regulatory agencies in Japan, South Korea and Canada, according to the release from Amgen and UCB. Evidence from the FRAME, ARCH and BRIDGE randomized controlled trials indicated that the monthly injection monoclonal antibody is superior to placebo and alendronate in preventing vertebral fractures, which the EMA noted despite its rejection.

“We are disappointed by the committee’s opinion and continue to believe that Evenity has a positive benefit:risk profile,” David M. Reese, MD, executive vice president of research and development at Amgen, said in the release. “Amgen and UCB remain committed to working with regulatory authorities around the world to bring Evenity to patients and physicians who need additional treatment options for osteoporosis.”

According to the EMA, a 15-day period exists in which an appeal of this decision can be made, which is an action Amgen and UCB plan to pursue, according to their joint release.