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Regeneron/Sanofi’s sBLA for Praluent to be Reviewed by FDA


Regeneron Pharmaceuticals, Inc. REGN along with its partner Sanofi SNY announced that the FDA will review the supplemental biologics license application (sBLA) for its PCSK9 inhibitor Praluent (alirocumab) injection. The sBLA seeks to get Praluent approved in a new indication – risk reduction of major adverse cardiovascular events (MACE). The FDA set an action date of Apr 28, 2019.

Shares of Regeneron have gained 4.7% year to date versus the industry’s decline of 4.6%.

The sBLA is supported by a phase III ODYSSEY OUTCOMES study. The study evaluated Praluent in (n=18,924) patients who suffered a recent acute coronary syndrome (ACS) event such as heart attack within one to 12 months prior to the trial. Results from this study were presented at the American College of Cardiology's 67th Annual Scientific Session & Expo in March 2018.

Praluent has not been evaluated by any regulatory body for cardiovascular morbidity and mortality and is current being reviewed for the same.

Last month, the FDA approved an update to the drug’s prescribing information for including clinical information regarding the use of Praluent in patients with heterozygous familial hypercholesterolemia (HeFH) who requires additional lowering of low-density lipoprotein cholesterol (LDL-C), accompanied with diet and maximally-tolerated statin therapy and are undergoing apheresis treatment. The drug can now be administered without attention paid to the timing of apheresis, with a recommended dosing of 150 mg once every two weeks in patients who are undergoing LDL apheresis.

We remind investors that Praluent was the first PCSK9 inhibitor to be approved (July 2015) in the United States. The drug was also approved in the EU (September 2015). The potential label expansion of Praluent will further drive the company’s growth. The drug recorded global net sales of $74 million in the first half of 2018.

However, although Praluent is the first PCSK9 drug for hypercholesterolemia to get FDA approval, Amgen’s AMGN Repatha is also approved in the United States, the EU and Japan, posing significant competition.

Zacks Rank & Another Stock to Consider

Regeneron currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the healthcare sector is Gilead Sciences, Inc. GILD, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead Sciences’ earnings estimates for 2018 and 2019 have moved 7.5% and 1.9% north, respectively, over the past 60 days. The stock has inched up 0.8% on a year-to-date basis.

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