|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
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