Gil Roth10.15.13
Portola Pharmaceuticals has posted new interim findings from a Phase II proof-of-concept study of its investigational Factor Xa inhibitor antidote, Andexanet alfa, in healthy volunteers who received the Factor Xa inhibitor Eliquis (apixaban). Andexanet alfa was administered intravenously as a bolus followed by a continuous infusion for up to two hours. Data from this study showed a rapid and nearly complete reversal of the anticoagulation effect of Eliquis measured at two minutes following completion of the bolus, which was sustained during infusion for up to two hours.
The safety follow-up for this study is ongoing with no serious adverse events or premature discontinuations of Andexanet alfa reported to date. Safety data for more than 65 healthy volunteers dosed with Andexanet alfa across Phase I and Phase II studies showed no thrombotic events or antibodies against Andexanet alfa, endogenous Factor Xa, or Factor X. One serious adverse event, a case of pneumonia, was seen in the Phase I study.
There are no approved agents for reversing or stopping the anticoagulant effect of novel Factor Xa inhibitors like Eliquis. Portola plans to begin Phase III trials in 2014 and hopes to receive an expedited approval process for the product.
The safety follow-up for this study is ongoing with no serious adverse events or premature discontinuations of Andexanet alfa reported to date. Safety data for more than 65 healthy volunteers dosed with Andexanet alfa across Phase I and Phase II studies showed no thrombotic events or antibodies against Andexanet alfa, endogenous Factor Xa, or Factor X. One serious adverse event, a case of pneumonia, was seen in the Phase I study.
There are no approved agents for reversing or stopping the anticoagulant effect of novel Factor Xa inhibitors like Eliquis. Portola plans to begin Phase III trials in 2014 and hopes to receive an expedited approval process for the product.