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Europe conditional Marketing Authorization for Ondexxya™

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H2R   Friday, 04/26/19 05:11:48 PM
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Europe conditional Marketing Authorization for Ondexxya™

https://seekingalpha.com/pr/17490076-european-commission-grants-conditional-marketing-authorization-portola-pharmaceuticals

Quote:


– 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 –

SOUTH SAN FRANCISCO, Calif., April 26, 2019 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (PTLA)® (Nasdaq: PTLA) today announced that the European Commission (EC) has granted conditional Marketing Authorization for Ondexxya™ (andexanet alfa). Ondexxya is the first and only antidote approved in Europe for adult patients treated with the Factor Xa inhibitor apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

“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 Jan Beyer-Westendorf, M.D., Head of the Thrombosis Research Unit, Department of Medicine I; Division Hematology, University Hospital Dresden, Germany. “As the number of European patients prescribed these Factor Xa inhibitors continues to increase, so too does the incidence of hospital admissions related to bleeding. The approval of Ondexxya represents a significant step forward in the treatment of these patients, who previously had no approved treatment option.”

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 New England Journal of Medicine – ANNEXA-R and ANNEXA-A in 2015, and ANNEXA-4 in February 2019.

“The unmet need for a reversal agent in Europe is significant, as the number of patients taking a Factor Xa inhibitor is nearly double that of the U.S. and continuing to grow at a significant rate. To help ensure we reach as many patients as quickly as possible, our initial launch efforts will be focused on a select group of countries where Factor Xa use is among the highest,” said Scott Garland, Portola’s president and chief executive officer. “We are very proud that, in just one year, we have achieved both U.S. and European approval of this potentially life-saving medicine and look forward to continuing to expand patient access in these countries and beyond.”

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 (FDA), as well as additional pharmacokinetic data.

Ondexxya was approved by the FDA in May 2018 and is marketed by Portola in the U.S. under the trade name Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo].



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