News | Antiplatelet and Anticoagulation Therapies | January 02, 2019

FDA Approves Portola Pharmaceuticals' Prior Approval Supplement for Andexxa Generation 2 Manufacturing Process

Approval expands patient access to first and only antidote for reversal of rivaroxaban or apixaban

FDA Approves Portola Pharmaceuticals' Prior Approval Supplement for Andexxa Generation 2 Manufacturing Process

January 2, 2019 — The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for its large-scale, second generation Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], allowing for broad commercial launch in the United States.

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was initially approved on May 3, 2018 under the FDA's Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to enoxaparin and warfarin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This growth has come with a related increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. In the U.S. alone in 2017, there were approximately 140,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding.

Read the article "FDA Clears First Reversal Agent for Rivaroxaban, Apixaban Anticoagulants"

For more information: www.portola.com

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