Pfizer and Bristol-Myers Squibb have suffered a setback on the news that regulators in the USA have delayed giving the green light to the firms’ much-touted bloodthinner Eliquis.
The US Food and Drug Administration has issued a complete response letter for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the CRL, the agency has requested additional information on data management and verification from Pfizer and B-MS’ 18,201-patient Phase III study, called Aristotle.
The companies noted that the FDA has not requested any new studies. B-MS chief scientific officer Elliott Sigal said the firm still believes that Aristotle and another large trial, Averroes, “have established the therapeutic profile for Eliquis and demonstrated a meaningful advance over the standard of care”, namely warfarin.