Amgen, Inc. (NASDAQ:AMGN) stock was down on Monday following results from a Phase 3 Evenity Arch study.
The Evenity Arch study from Amgen, Inc. was to test treating postmenopausal women with osteoporosis. The Amgen, Inc. study included treatments with Evenity injections once a month for 12 months and oral consumption of alendronate weekly for 12 months.
The goal of the Evenity Arch study was to determine how effective Evenity is at reducing fractures in postmenopausal women with osteoporosis. The drug met both its primary and secondary endpoints. However, there were serious adverse effects.
The study had patients taking Evenity and alendronate separately for 12 months. During this time, some of the women taking Evenity faced cardiovascular events. These women made up 2.5% of the patients in the Evenity group. 1.9% of women in the alendronate group saw serious cardiovascular events after the initial 12 months.
Amgen, Inc. says that the results of the Phase 3 Evenity Arch study are under review in several countries. This includes the United States’ Food and Drug Administration. Both AMGN and the FDA agree that the treatment should undergo a regulatory review before its initial marketing authorization. The biotechnology company says that this means it won’t come out in 2017, as it previously expected.
“The efficacy results from this study comparing Evenity to an active control are robust,” Sean Harper, M.D., the Executive Vice President of Research and Development at Amgen, Inc., said in a statement. “At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit:risk profile for Evenity.”
AMGN stock was down 2% as of noon Monday.
