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US Approval for Eliquis

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Recently, Bristol-Myers Squibb Company (BMY - Free Report) and partner Pfizer Inc. (PFE - Free Report) received some encouraging news when the US Food and Drug Administration (FDA) cleared their anti-clotting drug Eliquis (apixaban).

Eliquis was approved in the US for reducing the risk of strokes and systemic embolism in patients suffering from nonvalvular atrial fibrillation (NVAF). Atrial fibrillation refers to a cardiac rhythm disorder characterized by an erratic heartbeat. Bristol-Myers/Pfizer stated that they intend to issue a detailed press release about the approval shortly.

We note that the US approval process of Eliquis was anything but smooth. The companies had initially filed a new drug application (NDA) last year. The NDA included data from two phase III studies, ARISTOTLE and AVERROES. However, after reviewing the NDA, the US regulatory authority declined to approve Eliquis for the NVAF indication on the basis of the submitted data and issued a complete response letter (CRL) in June 2012.

While issuing the CRL, the FDA asked for additional information on data management and verification from the ARISTOTLE study. The FDA was satisfied with the resubmitted NDA and assigned a target date of March 17, 2013. However, the US regulatory body cleared Eliquis a couple of months before the target date.

The US approval of Eliquis for the NVAF indication comes close on the heels of the Japanese approval of the drug for the same indication. Eliquis has also been approved for the NVAF indication in the EU and Canada in 2012.

We note that the anti-coagulant market currently includes Bayer/Johnson & Johnson’s (BAYRY - Free Report) /(JNJ - Free Report) blood-thinner Xarelto. Moreover, the arrival of Boehringer Ingelheim’s Pradaxa has intensified competition in the market.

Neutral on Bristol-Myers/Pfizer

Currently, we have a long-term Neutral recommendation on Bristol-Myers. The stock carries a Zacks #3 Rank (Hold) in the short run. We have a similar stance on Pfizer. Large-cap pharma companies that currently look better-positioned include Novo Nordisk (NVO - Free Report) . Novo Nordisk carries a Zacks #2 Rank (Buy).

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