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Amgen Seeks FDA Approval for Repatha's New Dosing Option

Amgen Inc.AMGN has filed an application with the FDA seeking approval for a new delivery alternative of its PCSK9 inhibitor, Repatha (evolocumab). Amgen is looking to get the 420 mg monthly dose of Repatha approved as a single injection for administration.

We remind investors that Repatha gained FDA approval last month as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of bad cholesterol (LDL-C). It can also be used along with diet and other LDL-lowering treatments in patients with homozygous familial hypercholesterolemia, who require additional lowering of LDL-C.

Presently, Repatha is available for 140 mg/mL single-use prefilled autoinjector (SureClick) or syringe which requires three injections for a 420 mg dose. Once approved, the monthly single injection will provide patients with an additional and convenient dosing option.

Meanwhile, several outcomes studies (GLAGOV and FOURIER) on Repatha are currently underway. Results from GLAGOV - the intravascular ultrasound study - in coronary atherosclerosis patients undergoing cardiac catheterization is expected in 2016.

On the other hand, results from the FOURIER outcomes study evaluating the ability of Repatha to reduce the risk of recurrent cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease are expected no later than 2017. Positive data from these studies will boost the drug's sales potential, going ahead.

Repatha's approval in the U.S. follows Sanofi SNY and Regeneron Pharmaceuticals, Inc.'s REGN Praluent FDA approval in July this year. Praluent was the first PCSK9 inhibitor to gain regulatory clearance in the U.S. Several companies, including Pfizer Inc. PFE , are now looking to enter the market with their PCSK9 inhibitors.

We expect investor focus to remain on the sales ramp up of these potential multi-billion dollar drugs.

Amgen is a Zacks Rank #3 (Hold) stock. Regeneron is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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