Bristol-Myers Squibb ($BMY) and partner Pfizer ($PFE) have a new target date for FDA action on their bid to gain U.S. approval of their blockbuster hopeful Eliquis (apixaban). The agency has accepted the companies' resubmission of an NDA after twice delaying approval of the anti-clotting drug, with a new expected decision date of March 17, 2013.
Pfizer and Bristol saw their hopes for U.S. sales of Eliquis dashed this year after the FDA decided in March to delay by three months its decision on the drug and then in June issued a Complete Response Letter that sought more info on aspects of the companies' big ARISTOSTLE study, Forbes reported. The large study concluded that the new med bested warfarin in preventing stroke in patients with atrial fibrillation and resulted in lower mortality rates, according to results published in The New England Journal of Medicine last year.
The companies are aiming for a green light in the U.S. to sell Eliquis (which gained gained approval in Europe for use after certain surgeries) to reduce risk of stroke and embolism in patients with nonvalvular atrial fibrillation. Eliquis is among a crop of new anti-stroke drugs such as Boehringer Ingelheim's blockbuster blood-thinner Praxada as well as Bayer and Johnson & Johnson's ($JNJ) Xarelto.
Pfizer and Bristol reported the new FDA action date on Wednesday just days after announcing that European Union regulators recommended approval of Eliquis for patients with atrial fibrillation (Afib), a form of irregular heart beat. According to the companies, there are more than 5.8 million Americans and over 6 million Europeans with the condition. And the Afib indication is crucial to Eliquis in living up to analysts' multibillion-dollar annual sales projections.
- here's the release
- see Forbes' report