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Regeneron/Sanofi's PCSK9 Inhibitor Praluent Approved in EU

The European Commission (EC) approved Regeneron Pharmaceuticals, Inc.REGN and its partner Sanofi's SNY low-density lipoprotein (LDL) cholesterol lowering medication, Praluent. The EC approved Praluent for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet. The drug can be used both in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin and alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated.

We note that the effect of Praluent on cardiovascular (CV) morbidity and mortality has not yet been determined. The companies are evaluating the ability of Praluent to reduce major CV events in the ongoing ODYSSEY OUTCOMES study. Data from the study should mature in 2017.

Sanofi and Regeneron received a major boost when the FDA cleared Praluent earlier this year. The cholesterol management market offers huge commercial potential and Praluent is expected to generate multi-billion revenues.

Praluent is the second PCSK9 inhibitor to gain approval in the EU this year. In July, Amgen's AMGN Repatha was approved by the EC. Repatha's label is similar to Praluent's though Repatha is also approved for homozygous familial hypercholesterolemia (HoFH). Repatha has also gained approval in the U.S. With both the high-priced PCSK9 inhibitors, Repatha and Praluent, being pitted against each other, speculations about a potential price war is rife.

Regeneron is a Zacks Rank #1 (Strong Buy) stock. Amgen is also a favorably ranked stock given its Zacks Rank #2 (Buy). Another well-ranked stock in the health care sector is Gilead Sciences Inc. GILD , carrying the same Zacks Rank as Regeneron.

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REGENERON PHARM (REGN): Free Stock Analysis Report

SANOFI-AVENTIS (SNY): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

AMGEN INC (AMGN): Free Stock Analysis Report

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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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