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.
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Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.
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.
Cardiologists bemoaned high cost of new drugs and high hurdles for reimbursement at the American College of Cardiology annual meeting; will outcomes data save the day?