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Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff

 
• By Emily Hayes

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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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.

AndexXa (andexanet) had breakthrough therapy status with FDA for reversing effects of anticoagulants in emergency situations

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