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Amgen's PCSK9 Inhibitor, Repatha, Approved in the U.S.

The FDA approved Amgen’s AMGN new cholesterol-lowering medication, Repatha (evolocumab), making it the second PCSK9 inhibitor to gain approval in the U.S. this year. Repatha’s approval comes a month or so after the FDA approved Sanofi SNY and Regeneron’s REGN PCSK9 inhibitor, Praluent.

PCSK9 is a protein that lowers the liver's ability to remove "bad" cholesterol (LDL-C) from the blood.

According to Repatha’s label, it can be used 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 along with diet and other LDL-lowering treatments in patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.

The label is similar to Praluent’s label though Repatha is also approved for HoFH.

Pricing Matters

Repatha has been priced at $542.31 (wholesale acquisition cost) for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe – this comes to $14,100 annually for the every two weeks administration.

Meanwhile, Praluent is available at $40 (wholesale acquisition cost) per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses, which comes to approximately $14,600 annually.

Not surprisingly, Repatha has been priced at a small discount to Praluent. However, the real world price for both products could be lower depending on discounts and rebates.

Meanwhile, pharmacy benefit manager (PBM) Express Scripts ESRX, which played a major role in providing costly hepatitis C virus (HCV) treatments at a discount, said that despite the limited initial indications, PCSK9 inhibitors could end up becoming the most expensive therapy class in the U.S. over the next several years.

The PBM is targeting the greatest possible discounts for its clients and patients. The clinical profiles of both Repatha and Praluent will be reviewed by the PBM’s external Pharmacy & Therapeutics (P&T) Committee to be followed by formulary announcements. In this scenario, formulary coverage will remain a major focus area.

Our Take

The FDA approval of Repatha is good news for Amgen. Repatha has multi-billion dollar potential. While the initial indication looks limited, positive data from an ongoing outcomes study (due no later than 2017) would lead to a huge surge in sales. Both Repatha and Praluent are in outcomes studies that are being conducted to see whether PCSK9 inhibitors can cut the risk of recurrent cardiovascular events.

Meanwhile, the initial uptake of these drugs could be hampered by factors like pricing, physician reluctance to prescribe biologics for cholesterol reduction, patient discomfort regarding self-injections, reimbursement issues as well as low awareness regarding the urgency to cut bad cholesterol levels.

Amgen is a Zacks Rank #2 (Buy) stock. Regeneron is a better-ranked stock given its Zacks Rank #1 (Strong Buy).

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