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Portola Pharmaceuticals Inc. has resubmitted its biologics license application (BLA) for andexanet alfa (AndexXa®) to the US Food and Drug Administration (FDA).
With this BLA, Portola is seeking approval of andexanet alfa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
The resubmission includes supplemental information requested by the FDA in a complete response letter issued in August 2016.
At that time, Portola was seeking approval for andexanet alfa in patients treated with apixaban, rivaroxaban, edoxaban, or enoxaparin when reversal of anticoagulation is needed.
However, the FDA said it could not approve andexanet alfa for that indication. The FDA requested that Portola provide information related to manufacturing of andexanet alfa as well as additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label.
The initial BLA for andexanet alfa included data from a pair of phase 3 studies—ANNEXA-A and ANNEXA-R—which were designed to assess andexanet alfa’s ability to reverse the effects of apixaban and rivaroxaban—but not edoxaban or enoxaparin—in healthy volunteers.
Results from ANNEXA-A and ANNEXA-R were published in NEJM in 2015.
The BLA also included limited adjudicated efficacy and safety data from patients enrolled in the phase 3b/4 ANNEXA-4 study. This ongoing study is enrolling patients receiving apixaban, rivaroxaban, edoxaban, and enoxaparin who present with an acute major bleed.
Preliminary results from ANNEXA-4 were presented at ESC Congress 2016 and published in NEJM. 
Portola Pharmaceuticals Inc. has resubmitted its biologics license application (BLA) for andexanet alfa (AndexXa®) to the US Food and Drug Administration (FDA).
With this BLA, Portola is seeking approval of andexanet alfa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
The resubmission includes supplemental information requested by the FDA in a complete response letter issued in August 2016.
At that time, Portola was seeking approval for andexanet alfa in patients treated with apixaban, rivaroxaban, edoxaban, or enoxaparin when reversal of anticoagulation is needed.
However, the FDA said it could not approve andexanet alfa for that indication. The FDA requested that Portola provide information related to manufacturing of andexanet alfa as well as additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label.
The initial BLA for andexanet alfa included data from a pair of phase 3 studies—ANNEXA-A and ANNEXA-R—which were designed to assess andexanet alfa’s ability to reverse the effects of apixaban and rivaroxaban—but not edoxaban or enoxaparin—in healthy volunteers.
Results from ANNEXA-A and ANNEXA-R were published in NEJM in 2015.
The BLA also included limited adjudicated efficacy and safety data from patients enrolled in the phase 3b/4 ANNEXA-4 study. This ongoing study is enrolling patients receiving apixaban, rivaroxaban, edoxaban, and enoxaparin who present with an acute major bleed.
Preliminary results from ANNEXA-4 were presented at ESC Congress 2016 and published in NEJM.
Portola Pharmaceuticals Inc. has resubmitted its biologics license application (BLA) for andexanet alfa (AndexXa®) to the US Food and Drug Administration (FDA).
With this BLA, Portola is seeking approval of andexanet alfa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
The resubmission includes supplemental information requested by the FDA in a complete response letter issued in August 2016.
At that time, Portola was seeking approval for andexanet alfa in patients treated with apixaban, rivaroxaban, edoxaban, or enoxaparin when reversal of anticoagulation is needed.
However, the FDA said it could not approve andexanet alfa for that indication. The FDA requested that Portola provide information related to manufacturing of andexanet alfa as well as additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label.
The initial BLA for andexanet alfa included data from a pair of phase 3 studies—ANNEXA-A and ANNEXA-R—which were designed to assess andexanet alfa’s ability to reverse the effects of apixaban and rivaroxaban—but not edoxaban or enoxaparin—in healthy volunteers.
Results from ANNEXA-A and ANNEXA-R were published in NEJM in 2015.
The BLA also included limited adjudicated efficacy and safety data from patients enrolled in the phase 3b/4 ANNEXA-4 study. This ongoing study is enrolling patients receiving apixaban, rivaroxaban, edoxaban, and enoxaparin who present with an acute major bleed.
Preliminary results from ANNEXA-4 were presented at ESC Congress 2016 and published in NEJM.