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EMA’s CHMP Rejects Another Drug Approved by US FDA

Posted 28 June 2019 | By Zachary Brennan 

EMA’s CHMP Rejects Another Drug Approved by US FDA

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday adopted a negative opinion for UCB Pharma’s osteoporosis treatment Evenity (romosozumab), which was approved by the US Food and Drug Administration (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.

“In addition, when all the data were looked at together, there were more deaths in patients aged over 75 years given the medicine. 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,” CHMP said.

And although Evenity was effective in reducing the risk of fracture in patients with severe osteoporosis, CHMP said, the benefit “was not so convincing in patients with less severe disease.” Amgen and UCB said they intend to submit a written notice for a re-examination by CHMP.

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.

And CHMP last month adopted a negative opinion for Emmaus’s sickle cell disease drug Xyndari (glutamine), which is approved in the US. Emmaus has since requested a re-review from CHMP.

In 2018, CHMP also adopted negative opinions for two medicines approved by FDA in 2017 — Dexxience (betrixaban) to prevent venous thromboembolism and Eladynos (abaloparatide) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.


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