The US approval process of Bristol-Myers Squibb Company/Pfizer Inc.’s (BMY/PFE) 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 17, 2013.
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 (NVAFF). 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 compete with Bayer/Johnson & Johnson’s (BAYRY /JNJ) 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.
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