Biotech Stocks Facing FDA Decision In December


Amgen Inc.'s (AMGN) supplemental Biologics License Application of Repatha to include risk reduction of major adverse cardiovascular events in the Prescribing Information is under priority review by the FDA – with a decision expected on December 2, 2017.

The cholesterol lowering drug Repatha, which belongs to a class known as PCSK9 inhibitors, received FDA approval on August 27, 2015.

The supplemental Biologics License Application for Repatha was based on data from cardiovascular outcomes study, known as FOURIER. The study found that adding Repatha to optimized statin therapy resulted in a statistically significant 15 percent reduction in the risk of the extended major adverse cardiovascular events like hospitalization for unstable angina, heart attack, stroke or cardiovascular death.

Repatha generated modest annual sales of $141 million in 2016 and quarterly sales of $89 million in the recent third quarter of 2017.

AMGN closed Tuesday’s (Nov.28) trading at $170.26, up 0.32%.