FDA again delays approval of Bristol-Myers and Pfizer's Eliquis

26 June 2012

A few days ahead of the expected decision date, the US Food and Drug Administration on Monday issued a complete response letter (CRL) regarding Bristol-Myers Squibb (NYSE: BMY) and Pfizer’s (NYSE: PFE) New Drug Application for their anticoagulant Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The agency put Eliquis on “fast track” last year, indicating early approval.

The news, which came as a surprise since the agency had been expected to clear the drug by the end of this month, saw B-MS’ shares fall 5.1% to $33.55 in premarket trading, and those of Pfizer decrease 2.3% to $22.20. Last week, the FDA also delayed approval of Bayer’s rival anticoagulant Xarelto (rivaroxaban) in combination with standard antiplatelet therapy for the reduction of secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with acute coronary syndrome (The Pharma Letter June 22).

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