Bristol-Myers Squibb Company (BMY) and partner Pfizer Inc. (PFE) recently announced that their supplemental New Drug Application (sNDA) for Eliquis has been accepted by the US Food and Drug Administration (FDA). The companies are looking to get the drug approved for the prevention of deep vein thrombosis (DVT) in adults who have undergone hip or knee replacement surgery.
We note that DVT can lead to pulmonary embolism (PE), which can be fatal. The FDA is expected to render a final decision on the drug by Mar 15, 2014.
The sNDA was submitted on the basis of data from ADVANCE-1 and ADVANCE-2 (evaluating the use of Eliquis in patients undergoing elective total knee replacement) and ADVANCE-3 (evaluating the use of Eliquis in patients undergoing elective hip replacement) along with a part of the EXPANSE program. These trials compared the safety and efficacy of Eliquis to Sanofi’s (SNY) Lovenox (enoxaparin).
We note that Eliquis, a Factor Xa inhibitor, was launched in multiple countries including the US and EU for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the first quarter of 2013. We believe that the label expansion of the drug will boost its sales potential.
Eliquis is also approved in the EU and some other nations for prevention of venous thromboembolic events (VTE) events in adults, who have undergone elective hip or knee replacement surgery.
Other Factor Xa inhibitors currently available in the market include Xarelto, which is approved for several indications including prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
While Bristol-Myers carries a Zacks Rank #4 (Sell), Pfizer carries a Zacks Rank #3 (Hold). Jazz Pharmaceuticals (JAZZ) appears to be more attractive with a Zacks Rank #1 (Strong Buy).
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