A negative heart safety signal picked up in a clinical study of Amgen's Evenity means the product will not be approved and on the U.S. market this year, as previously expected.
The news from Amgen over the weekend "will likely be seen as a providing a commercial boost to Radius Health, which secured U.S. approval in April for a competing osteoporosis drug, Tymlos," wrote TheStreet's Adam Feuerstein.
Shares of Amgen were trading at $152.90, down 2.3%.
Thousand Oaks, Calif.-based Amgen and Brussels-based UCB on Sunday announced that a phase three study of Evenity in postmenopausal women with osteoporosis met both primary endpoints and the key secondary endpoint. However, the firms also said that an imbalance "in positively adjudicated cardiovascular serious adverse events was observed as a new safety signal."
Amgen said it does not expect approval of Evenity in the U.S. this year.
"We are working on understanding the observed cardiovascular safety signal and will continue to discuss these results with global regulators and experts in the field," said Iris Loew-Friedrich, chief medical officer of UCB, in the news release.
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