FDA acknowledges receipt of resubmission of apixaban’s new drug application

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Bristol-Myers Squibb and Pfizer have announced that the US Food and Drug Administration (FDA) has acknowledged receipt of the new drug application (NDA) resubmission for apixaban (Eliquis) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).

The FDA assigned a new prescription drug user fee act (PDUFA) goal date of 17 March 2013. The FDA has deemed the resubmission a complete response to its 22 June 2012 complete response letter that requested additional information on data management and verification from the ARISTOTLE trial.

The new drug application for apixaban is based on the results of the ARISTOTLE and AVERROES studies. These clinical studies evaluated apixaban in approximately 24,000 patients with NVAF, in the largest clinical trial programme conducted to date in this patient population. The landmark ARISTOTLE trial compared apixaban to warfarin, the standard of care, in more than 18,000 NVAF patients, while AVERROES compared apixaban to aspirin in 5,598 NVAF patients who were unsuitable for vitamin K antagonist (VKA) therapy.


ARISTOTLE and AVERROES are part of an ongoing clinical development programme for apixaban, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomised, double-blind phase III trials.


The companies continue to progress the apixaban application for stroke prevention in atrial fibrillation in markets outside of the USA, including the European Union and Japan, based on the ARISTOTLE and AVERROES studies. On 21 September 2012, Bristol-Myers Squibb and Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that apixaban be granted approval for the prevention of stroke and systemic embolism in adult patients with NVAF and with one or more risk factors for stroke.

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