Bristol-Myers Squibb Company
) and partner
) received some encouraging news when the US Food and Drug
Administration (FDA) cleared their anti-clotting drug Eliquis
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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
Johnson & Johnson
) 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 carries a Zacks #2 Rank (Buy).