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Portola Pharmaceuticals Announces Results of CHMP Oral Explanations for Andexanet Alfa and Betrixaban
Portola will host a webcast and conference call on
“We are very pleased with the favorable outcome of the oral explanation for andexanet alfa, and remain confident in our path forward to approval,” said
Portola is seeking conditional approval for andexanet alfa for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
Andexanet alfa is also currently under review by the
The CHMP communicated a negative trend vote for betrixaban for the prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE. A negative trend vote means it is unlikely that the CHMP will adopt a positive opinion on the Company’s MAA at the formal CHMP decision vote scheduled for
The CHMP’s position is that betrixaban efficacy is acknowledged in the APEX trial, but uncertainties remain regarding a positive benefit risk, which is not supported by a second confirmatory study, biological plausibility for betrixaban in another approved indication or external support within the class from other Factor Xa inhibitors, which are not approved for the acute medically ill population.
“We are disappointed with the Committee’s interpretation on betrixaban given the unmet medical need, the clinically meaningful outcomes of the APEX trial and the broad label we received to treat acute medically ill patients in the U.S.,” said Lis. “We are considering our next steps in
Conference Call Details
The live conference call, scheduled for
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. For more information, visit http://www.portola.com and follow the Company on Twitter @Portola_Pharma.
This announcement contains forward-looking statements, including statements relating to Portola Pharmaceuticals’ expectations regarding the regulatory status of betrixaban and andexanet alfa. These statements are subject to significant risks and uncertainties, and actual results could differ materially from those projected. These risks and uncertainties include, without limitation, risks and uncertainties related to the regulatory process for betrixaban and andexanet alfa in Europe. Risks and uncertainties relating to Portola Pharmaceuticals and its business can be found in the “Risk Factors” section of Portola Pharmaceuticals’ Quarterly Report on Form 10-Q for the third quarter of 2017, which was filed with the SEC on November 9, 2017. Portola Pharmaceuticals cautions investors not to place undue reliance on the forward-looking statements contained in this release. Portola Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Portola Pharmaceuticals’ expectations.