Bristol-Myers Squibb Company
) and partner Pfizer (
) 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 (
) 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 (
), sporting a Zacks Rank #1 (Strong Buy).
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