Amgen Evenity Approval Derailed On Cardiovascular Side Effect
Zacks Investment Research | May 22, 2017 08:52AM ET
A late-stage study at Amgen, Inc. (NASDAQ:AMGN) showed that its pipeline candidate Evenity/romosozumab led to a statistically significant superior fracture risk reduction in postmenopausal women with osteoporosis than Merck & Co., Inc.’s (NYSE:MRK) Fosamax (alendronate), which is the current standard of care in osteoporosis. However, a cardiovascular side effect was observed in the study, following which Amgen does not expect Evenity to get FDA approval this year.
The phase III ARCH study compared 12 months of treatment with the subcutaneous injection of Evenity monthly followed by 12 months of Fosamax compared to Fosamax alone in postmenopausal women with osteoporosis at a high risk for fracture
At the primary analysis, the Evenity+Fosamax arm significantly reduced the incidence of new vertebral fractures through 24 months, clinical fractures (primary endpoints) and non-vertebral fractures (key secondary endpoint) in the above mentioned patients, compared to Fosamax alone.
However, an imbalance in cardiovascular safety signal was observed in the study, which management said will be assessed as part of the overall benefit risk profile for Evenity.
The incidence of positively adjudicated cardiovascular serious adverse events at 12 months was 2.5% in the Evenity-arm compared with 1.9% in the Fosamax arm.
Evenity/romosozumab is presently under review in the U.S. for the treatment of osteoporosis in postmenopausal women at increased risk for fracture with a decision expected on Jul 19, 2017. This regulatory application was based on the FRAME study result. It is also under review in Canada and Japan for the same indication.
However, the safety data from the ARCH data will now be considered in the regulatory review as agreed with the FDA. Following the new heart-related safety issue that emerged from the otherwise successful ARCH results, Amgen does not expect Evenity to be approved this year.
Shares of Amgen were down 1% on Friday. However, so far this year, Amgen’s shares are up 7%, better than the 0.4% increase registered by the Zacks classified Original post
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