28 June 2019 - The EMA CHMP on Friday adopted a negative opinion for UCB Pharma’s osteoporosis treatment Evenity (romosozumab), which was approved by the US FDA in April.

CHMP said the rejection followed concerns that patients given Evenity had an increased risk of serious heart or circulatory system effects, such as heart attacks or strokes.

FDA, meanwhile, noted the benefits of Evenity (romosozumab-aqqg), marketed by Amgen in the US, from two clinical trials involving more than 11,000 women with postmenopausal osteoporosis. The agency also added a boxed warning on the drug’s labeling, “stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.” Evenity also won approval in Japan.

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