Portola Defends AndexXa Antidote Safety, Says Thrombotic Events In Line
Executive Summary
Interim analysis of ANNEXA-4 study published in NEJM supports case for AndexXa approval, but 18% thrombosis rate raised some eyebrows.
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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.