Musings on apixaban: The EU MAA for VTE prevention is on track for submission in 1H10, according to BMY’s 4Q09 CC. However, there is not even a rough timeline from BMY/PFE on the timing of an NDA submission to the FDA.
I presume that the FDA has informally signaled that the apixaban data to date in VTE prevention are wanting and at least one additional trial is needed for approval in this indication. I further presume that, given the competitive landscape, BMY/PFE aren’t sure the VTE-prevention indication in the US is worth the additional investment the FDA requires.
Although the apixaban program hasn’t worked out as well as it might have, I give BMY a credit for inking the 2007 deal with PFE whereby BMY recouped $250M of its investment in up-front cash (#msg-19134406). Does anyone think Peter Dolan would have done this kind of deal (LOL)?
Apixaban has received a positive opinion from the CHMP, for the prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery. Approval is almost certain.
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