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Portola's Xarelto/Eliquis Antidote To Be Refiled Next Year

 
• By Sukaina Virji

Portola plans to resubmit the crucial BLA for its anticoagulant reversal agent AndexXa 'in the second quarter of 2017' after its unexpected August CRL. An approval would shore up the commercial success of Xarelto and Eliquis. Meanwhile, it has filed an NDA for its own Factor Xa inhibitor, betrixaban.

Portola Pharmaceuticals Inc. suffered a surprise setback in August this year when its reversal agent AndexXa (andexanet) was the subject of a complete response letter from the US FDA. (Also see "Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff" - Scrip, 19 August, 2016.)

Portola was hoping to secure approval for its reversing effects to the Factor Xa inhibitors Johnson & Johnson/Bayer...

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