Amgen announced that the U.S. FDA has granted priority review for Amgen's supplemental Biologics License Application for Repatha, which seeks to update the prescribing information to include risk reduction of major cardiovascular events.
The FDA will decide by Dec. 2 whether to allow Amgen to include data from a major clinical trial that showed the pricey injectable cholesterol drug significantly cut the risk of heart attack, stroke and death.
Amgen cannot promote the heart safety data until it is officially included in the prescribing information.
"The FDA's decision to grant priority review for the Repatha cardiovascular outcomes data highlights the urgency to address the need to reduce heart attacks and strokes in high-risk patients who struggle to lower their LDL cholesterol," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
Read the press release