FDA/CDC

First reversal agent for apixaban and rivaroxaban gets fast-track approval


 


He noted at the time the results placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind) approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa)

“The expansion of available reversal agents for people prescribed newer oral anticoagulant therapies is crucial,” Randy Fenninger, chief executive officer of the National Blood Clot Alliance, said in the Portola statement. “The availability now of a reversal agent specific to rivaroxaban and apixaban expands choice and enables patients and providers to consider these treatment options with greater confidence.”

The prescribing information for andexanet states that treated patients should be monitored for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. Further, anticoagulant therapy should be resumed as soon as medically appropriate following andexanet treatment to reduce thromboembolic risk.

The most common adverse reactions, occurring in at least 5% of patients, were urinary tract infections and pneumonia.

Portola intends to bring Andexxa to limited markets in early June; a broader commercial launch is anticipated in early 2019.*

The FDA is requiring a postmarketing clinical trial that randomizes patients to either andexanet or usual care. The study is scheduled to begin in 2019 and report outcomes in 2023.

*This article was updated on May 7, 2018.

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