Portola had assumed these studies would be sufficient because, overall, the research suggests andexanet alfa has broad activity against factor Xa inhibitors, according to Bill Lis, chief executive officer of Portola. Andexanet alfa’s effects on edoxaban and enoxaparin have been investigated in phase 2 studies, however. The completed phase 3 studies of andexanet alfa were designed to assess the drug’s ability to reverse the effects of apixaban and rivaroxaban-but not edoxaban or enoxaparin-in healthy volunteers. The FDA also asked Portola for additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label. Portola said it could not provide many details on this request but stressed that the FDA did not question the company’s ability to manufacture the drug. In the complete response letter, the FDA requested that Portola Pharmaceuticals Inc., the company developing andexanet alfa, provide additional information related to manufacturing.
The agent is intended to be used when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
#Enoxaparin antidote license#
The US Food and Drug Administration (FDA) has issued a complete response letter regarding the biologics license application for andexanet alfa (AndexXa™).Īndexanet alfa is being developed as a reversal agent for the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, and enoxaparin.
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