Fears that Portola Pharmaceuticals Inc.'s AndexXa (andexanet alfa) would face further years of delay in getting approved in the US as an antidote for Factor Xa anticoagulants are unfounded now that the FDA has given the green light, albeit with a black box warning.
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.
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