By PPN News Staff
The FDA sent a complete response letter (CRL) to Portola Pharmaceuticals Inc. regarding its Biologics License Application (BLA) for andexanet alfa (AndexXa) asking for more information.
An FDA-designated breakthrough therapy, andexanet alfa is in development for patients treated with a direct (apixaban [Eliquis, Bristol-Myers Squibb], edoxaban [Savaysa, Daiichi Sankyo] or rivaroxaban [Xarelto, Janssen]) or indirect (enoxaparin) factor Xa inhibitor when reversal of