Where Cholesterol Surrogates Stand After ACC '16
Failure of another CETP inhibitor – Lilly’s evacetrapib – despite robust LDL-lowering raises more doubt about surrogates, yet doesn’t put too much of a damper on PCSK9 inhibitors at the annual American College of Cardiology meeting. Statins get another boost just ahead of entry of Crestor generics.
You may also be interested in...
Inflammation A Clue Left In ACCELERATE CETP Wreckage
Blood pressure and C-reactive protein were modestly increased in the ACCELERATE trial of Lilly’s CETP inhibitor evacetrapib, but what exactly torpedoed the trial is still a mystery.
FDA’s Zetia/Vytorin Rejection Leaves Cholesterol Drug Sponsors In Limbo
FDA’s complete response letter for the cardiovascular risk reduction claim for Zetia/Vytorin was expected, but what will this mean for sponsors of drugs with other mechanisms, like PCSK9?
PCSK9 Inhibitors May Feel Effects Of FDA Judgment On IMPROVE-IT
Agency's decision on cardiovascular risk reduction claims for Merck's Zetia and Vytorin may serve as a regulatory barometer for the magnitude and robustness of effect that will be expected in outcomes studies for other LDL-C-lowering agents.