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Portola Launches European Sales of Ondexxya® (Andexanet Alfa) with First Orders in Europe
"The number of Europeans taking a Factor Xa inhibitor is nearly double that of the U.S. and continues to grow at a significant rate. The speed with which these first European orders were received and the number of medical societies that have already added Ondexxya to their guidelines speaks to the potential unmet need and demand for Ondexxya," said
"As the first and only Factor Xa reversal agent approved in
The worldwide use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to warfarin and enoxaparin 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. Prior to its approval in
Ondexxya is a recombinant protein specifically designed to bind to Factor Xa inhibitors and rapidly reverse their anticoagulant effect. Ondexxya is a modified form of the human Factor Xa molecule, an enzyme that helps blood clot. It works by acting as a decoy for oral and injectable Factor Xa inhibitors, which target and bind to Factor Xa. When Ondexxya is given to a patient with Factor Xa inhibitor-related bleeding, it binds to the Factor Xa inhibitor and prevents it from inhibiting the activity of Factor Xa and reverses the anticoagulant effects of the inhibitor.
Please refer to full SmPC for further information on side effects reported with Ondexxya.
For additional Important Safety Information and Andexxa's full Prescribing Information, please visit http://www.Andexxa.com.
IMPORTANT INFORMATION FOR ANDEXXA [coagulation factor Xa (recombinant), inactivated-zhzo]
BOXED WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST AND SUDDEN DEATHS
See full prescribing information for complete boxed warning
Treatment with Andexxa has been associated with serious and life‑threatening adverse events, including:
- Arterial and venous thromboembolic events
- Ischemic events, including myocardial infarction and ischemic stroke
- Cardiac arrest
- Sudden deaths
Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
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 anticipated launch timing and strategy for Ondexxya in
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Investor Contact: Cara Miller, Portola Pharmaceuticals, IR@portola.com or Media Contact: Julie Normart, Pure Communications, email@example.com