Posted by Michael Wonder on 29 Jul 2017
FDA grants priority review for Amgen's supplemental biologics license application for Repatha (evolocumab) to include data on reducing risk of cardiovascular events
28 July 2017 - FDA priority review status underscores need to reduce heart attacks and strokes.
Amgen today announced that the U.S. FDA has granted priority review for Amgen's supplemental biologics license application for Repatha (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER).
The FDA has set a Prescription Drug User Fee Act action date of 2 December 2017.
