FDA Accepts Review of Biologics License Application Resubmission Bleeding Event Treatment

The FDA recently accepted a resubmitted Biologics License Application (BLA) from Portola Pharmaceuticals for andexanet alfa (AndexXa).

Andexanet alfa is a modified human Factor Xa molecule designed to behave as a decoy to target and sequester both oral and injectable Factor Xa inhibitors in the blood, according to a press release.

As requested by the FDA in a complete response letter issued to the drugmaker last year, the resubmission includes supplemental information primarily related to analytics and manufacturing.

The investigational drug is being developed as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who have had a serious uncontrolled or life-threatening bleeding event, or who require emergency urgent surgery.

The BLA seeks initial approval of andexanet alfa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients with uncontrolled or life-threatening bleeding.

Approximately 90,000 Americans treated with Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding in 2016. Furthermore, it is estimated that more than 150,000 patients in the United States could benefit from an antidote annually, including those taking enoxaparin—–the injectable Factor Xa inhibitor.

There are currently no FDA-approved Factor Xa inhibitor antidotes, according to the release. Andexanet alfa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity.

An action due date for andexanet alfa has been set for February 2, 2018.