Amgen Bone Drug Shows Heart Risks in Trial

May 22, 2017

Reuters

Amgen and UCB SA's experimental osteoporosis drug, Evenity, will struggle to to win U.S. FDA approval this year after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial.

Details were not disclosed, however Amgen revealed on Sunday that the drug raised unexpected heart-safety concerns.

The new safety data will have to be taken into consideration, delaying a decision from the FDA. The Agency had been expected to make a ruling in July.

Read the Reuters article