Bristol-Myers/Pfizer's Eliquis Gets Yet Another FDA Nod - Analyst Blog

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Bristol-Myers Squibb Company ( BMY ) and partner Pfizer ( PFE ) announced that the FDA has cleared their anti-clotting drug Eliquis for an additional indication. The U.S. regulatory body cleared the drug for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for bringing down the risk of recurrent DVT and PE after initial treatment. Approval was gained on the basis of positive results from two studies - AMPLIFY and AMPLIFY-EXT - on Eliquis. This is the second FDA approval for Eliquis this year.

In Mar 2014, the drug was cleared by the FDA to reduce the risk of blood clots in patients who have undergone hip or knee replacement surgery. In 2012, the drug gained FDA clearance for reducing the risk of stroke and systemic embolism in patients suffering from nonvalvular atrial fibrillation. Atrial fibrillation refers to a cardiac rhythm disorder characterized by an erratic heartbeat.

We note that the latest FDA approval of Eliquis comes close on the heels of the drug's EU clearance for the treatment of DVT and PE and the prevention of recurrent DVT and PE in adults.

We note that DVT refers to a blood clot in a vein (mostly in the lower leg, thigh or pelvis) resulting in blood flow obstruction. DVT can progress to PE (lung clots) which can prove fatal. Bristol-Myers stated in its press release that DVT and PE affect approximately 900,000 Americans annually. Consequently, the U.S. approval of Eliquis for treating leg and lung clots is a huge positive and will boost the blood thinner's sales potential. Eliquis recorded sales of $171 million in the second quarter of 2014. Bayer/Johnson & Johnson's ( BAYRY / JNJ ) Xarelto is also approved to treat the above types of blood clots.

Both Bristol-Myers and Pfizer are Zacks Ranked #3 (Hold) stocks. A better-ranked stock in the healthcare space is Gilead Sciences ( GILD ), sporting 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 The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: PE , BMY , PFE , BAYRY , GILD

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