Regulators in the USA will make a decision whether to finally approve Bristol-Myers Squibb and Pfizer's bloodthinner Eliquis for stroke prevention by St Patrick's Day next year.
In June, the US 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 requested additional information on data management and verification from Pfizer and B-MS' 18,201-patient Phase III study, called Aristotle, but no new studies were required.
Now the companies say the FDA has accepted the resubmission of data and assigned a new Prescription Drug User Fee Act goal date of March 17, 2013. The move comes less than a week after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the authorisation of Eliquis in the stroke/AF indication; the drug was approved in Europe for the prevention of venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery in May 2011.
If Pfizer and B-MS gets the US thumbs-up, it will compute with two new bloodthinners for stroke - Boehringer Ingelheim's Pradaxa (dabigatran) and Bayer/Johnson & Johnson's Xarelto (rivaroxaban), which like Eliquis is an oral Factor Xa inhibitor. Despite getting to market later than these two drugs, many analysts believe Eliquis, with its strong efficacy and safety profile, notably regarding bleeding episodes, will become the best-in-class product.