Amgen (AMGN) Repatha Meets Endpoints in Phase III Study

Amgen, Inc. AMGN announced positive top-line results from a phase III study evaluating the effect of its cholesterol-lowering medication, Repatha (evolocumab), in patients with coronary artery disease (CAD).

Repatha, a PCSK9 inhibitor, is approved for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of bad cholesterol. It can also be used with diet and other LDL-lowering treatments in patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.

The multicenter, double-blind, randomized, placebo-controlled GLAGOV trial (n=968) was conducted to see whether treatment with Repatha modifies atherosclerotic plaque build-up in coronary arteries of patients already treated with optimized statin therapy. The study, in which patients were given either monthly Repatha 420 mg or placebo subcutaneous injections, showed that Repatha modifies the underlying process of atherosclerosis, a major cause of cardiovascular disease.

This study met the primary as well as secondary endpoints. The primary endpoint was the change in percent atheroma volume (PAV) from baseline to week 78 as measured by intravascular ultrasound (IVUS). Detailed results from the trial will be presented at the American Heart Association (AHA) meeting in November.




Results from the phase III study, evaluating the effects of Repatha on cardiovascular outcomes, are expected in the first quarter of 2017. The study is being conducted to see whether PCSK9 inhibitors can reduce the risk of recurrent cardiovascular events. Repatha sales are yet to pick up even though it was launched last year, due to the drug facing a difficult access and reimbursement environment among other things. However, positive data from the outcomes study are expected to lead to a surge in sales.

This July, Amgen announced that the FDA has approved a new monthly, single-dose administration option for Repatha. The Repatha Pushtronex system, an on-body infusor with a prefilled cartridge, is a hands-free device intended to administer 420 mg in a single dose. The approval makes Repatha the first and only PCSK9 inhibitor to have a monthly single-dose delivery option.

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Geron Corporation GERN, Anika Therapeutics Inc. ANIK and ANI Pharmaceuticals, Inc. ANIP. All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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