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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Portola Finally Gets FDA OK For Factor Xa Antidote AndexXa
It has taken a while and there were concerns that another trial may be needed before approval but AndexXa has got the green light in the US as a reversal agent for Eliquis and Xarelto. It comes with a warning and post-marketing commitments but Portola has very high hopes.