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