Bristol-Myers Squibb Company
) and partner
) received some encouraging news with the European Commission
(EC) clearing their anti-clotting drug Eliquis (apixaban) in the
EU. The approval in the EU marks the first approval of the drug
for the NVAF indication.
Eliquis was approved in the EU for preventing strokes and
systemic embolism in adults suffering from nonvalvular atrial
fibrillation (NVAF) along with one or more risk factors for
stroke. Atrial fibrillation refers to a cardiac rhythm disorder
characterized by an erratic heartbeat.
Approval was based on data from two phase III studies,
ARISTOTLE and AVERROES. The studies evaluated approximately
24,000 patients suffering from NVAF.
The approval by the EC did not come as a surprise, as the
European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) had recommended the approval of the
anti-clotting drug in September 2012.
Eliquis, on being launched, would face intense competition in
the anti-coagulant market. The drug will have to compete with
Johnson & Johnson'
) blood-thinner Xarelto. Moreover, the arrival of Boehringer
Ingelheim's Pradaxa has intensified competition in the
We note that the US approval process of Eliquis for the NVAF
indication is on track. The US Food and Drug Administration (FDA)
is expected to decide on whether to approve Eliquis for the
indication by March 17, 2013. Positive news from the FDA would
boost the sales potential of the drug.
Neutral on Bristol-Myers/Pfizer
Currently, we have a long-term Neutral recommendation on
Bristol-Myers. The stock carries a Zacks #3 Rank (Hold rating) in
the short run. We have a similar stance on Pfizer.
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