Bristol-Myers/Pfizer's Eliquis Encourages in VTE Analysis
Bristol-Myers Squibb Company (BMY) and partner Pfizer (PFE) announced encouraging data from a pre-specified secondary analysis of a phase III study (AMPLIFY-EXT: n= 2, 486) on their anticoagulant Eliquis across two doses (2.5 mg and 5 mg). The analysis assessed the predictors (clinical and demographic) of hospitalization in patients suffering from venous thromboembolism (:VTE), at the ESC Congress in Spain.
VTE includes deep vein thrombosis (DVT.V) and pulmonary embolism (PE). 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.
Results from the analysis of the study revealed that treatment with Eliquis during the 12-month extended period significantly brought down the risk of hospitalization as compared to patients treated with placebo. The encouraging results from the secondary analysis were not dependent on any other predictor of hospitalization. We are encouraged by the positive data from the secondary analysis of the phase III study on Eliquis.
We remind investors that the drug has recently been approved by the FDA on the basis of positive results from the AMPLIFY and AMPLIFY-EXT studies for the treatment of DVT and PE and for bringing down the risk of recurrent DVT and PE after initial therapy. This was 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. The drug was also cleared in the EU for the treatment of DVT and PE and the prevention of recurrent DVT and PE in adults this year.
Sales of Eliquis, which have been nothing but modest since launch, should pick up following the approvals gained this year for new indications.
Both Bristol-Myers and Pfizer carry a Zacks Rank #3 (Hold). Better-ranked stocks in the health care space include Gilead Sciences (GILD) and Celgene Corporation (CELG). While Celgene carries a Zacks Rank #2 (Buy), Gilead is a Zacks Ranked #1 (Strong Buy) stock.
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