The US approval process of
Bristol-Myers Squibb Company
) anti-clotting drug Eliquis (apixaban) is back on track with the
US Food and Drug Administration (FDA) accepting the companies'
response to the complete response letter (CRL) issued by the US
agency in June 2012. A decision from the FDA is expected by March
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We note that Bristol-Myers and Pfizer are looking to get Eliquis
approved in the US for bringing down 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.
We remind investors that 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 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 the new target date.
We note that the European approval process of Eliquis for
preventing strokes and systemic embolism in NVAF patients in
addition to one or more risk factors for stroke is on track.
Earlier in the month, the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) recommended
the approval of Eliquis for the indication.
The European Commission (EC) will take the final decision on
Eliquis' approval after reviewing the CHMP's opinion. The EC's
decision will be binding on the 27 member states of the EU in
addition to Iceland and Norway.
If Eliquis manages to gain approval, it would face intense
competition in the anti-coagulant market. Eliquis will have to
Bayer/Johnson & Johnson
) blood-thinner Xarelto. Moreover, the arrival of Boehringer
Ingelheim's Pradaxa has intensified competition in the market.
We remind investors that Eliquis was cleared in the EU last year
for preventing venous thromboembolic events (VTE) in adults, who
have undergone elective hip or knee replacement surgery. However,
the atrial fibrillation market is more lucrative.
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.