Portola Pharmaceuticals Inc. will be pursuing a narrower label for its reversal agent AndexXa in treating patients exposed to Eliquis and Xarelto – the novel anticoagulants with the largest market shares – following a complete response letter from FDA.
Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff
Company had wanted accelerated approval for the antidote for all Factor Xa inhibitors, but will now focus the reversal agent on the two drugs commanding the largest markets – Bristol/Pfizer's Eliquis and J&J/Bayer's Xarelto.
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