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European Commission Grants Conditional Marketing Authorization for Portola Pharmaceuticals’ Ondexxya™ (andexanet alfa), the First and Only Antidote for the Reversal of Factor Xa Inhibitors
– Major Advance in the Treatment of European Factor Xa Inhibitor Patients Hospitalized
with Life-Threatening Bleeding –
– Initial Launch in Select Countries to Begin 2H 2019 –
“The medical community has been eagerly anticipating the approval of Ondexxya and the ability to rapidly reverse the anticoagulating effects of rivaroxaban or apixaban,” said
The conditional approval of Ondexxya was based on data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) that evaluated the safety and efficacy of Ondexxya in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban or apixaban in healthy subjects, and data from the Phase 3b/4 ANNEXA-4 study that evaluated efficacy and safety data from 352 bleeding patients. Results from all three studies were published in
“The unmet need for a reversal agent in
The EC grants conditional authorizations to medicines that fulfill a medical need and show a potential benefit to public health, and for which additional data are required by the EC. As part of the conditional approval, Portola will provide the final study reports for both the ANNEXA-4 trial and the randomized controlled clinical trial requested by the U.S. Food and Drug Administration (
Ondexxya was approved by the
Important Safety Information
The most frequently reported adverse reactions in clinical trials in healthy subjects with Ondexxya were mild or moderate infusion-related reactions comprising symptoms such as flushing and feeling hot (very common), and cough, dysgeusia, and dyspnoea (common). Amongst bleeding patients, commonly reported side effects were ischaemic stroke and pyrexia, with uncommonly reported side effects of cerebral infarction, cerebrovascular accident, transient ischaemic attack, acute myocardial infarction, cardiac arrest, myocardial infarction, deep vein thrombosis, iliac artery occlusion, pulmonary embolism.
Please refer to full SmPC for further information on side effects reported with Ondexxya.
The U.S. full prescribing information for Andexxa is available at www.andexxa.com
Portola Pharmaceuticals is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s two FDA-approved medicines are Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, and Bevyxxa® (betrixaban), the first and only oral, once-daily Factor Xa inhibitor for the prevention of VTE in adult patients hospitalized for an acute medical illness. The company also is advancing cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers.
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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|Cara Miller||Julie Normart|
|Portola Pharmaceuticals||Pure Communications|
Source: Portola Pharmaceuticals, Inc.