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Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa™ (andexanet alfa)
In the CRL for AndexXa, the
“Because AndexXa addresses an urgent unmet medical need, we and the
Conference Call Details
The Portola management team will host a conference call and webcast tomorrow,
About the Need for a Factor Xa Inhibitor Antidote
Annually, 1 to 4 percent of patients treated with Factor Xa inhibitors may experience major bleeding, and an additional 1 percent may require emergency surgery. Commensurate with the increase in the use of Factor Xa inhibitors -- for stroke prevention in atrial fibrillation; treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT following knee or hip replacement surgery -- the number of hospital admissions due to bleeding associated with these agents continues to grow. In
AndexXa, an investigational drug, is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus potentially allowing for the restoration of normal hemostatic processes. AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity – the anticoagulant mechanism of these agents.
Portola’s BLA for AndexXa was based on data from two Phase 3 ANNEXA™ studies that evaluated the safety and efficacy of AndexXa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in older healthy volunteers. Results of those studies were published online by
The BLA also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study. Portola is currently evaluating AndexXa in this global, Phase 3b/4 single-arm, open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential future regulatory approval of AndexXa. Risks that contribute to the uncertain nature of the forward-looking statements include the risk that we may be unable to satisfy the FDA’s requirements for such approval. These and other risks and uncertainties are described more fully in our most recent filings with the
Ana Kapor Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com