Portola Receives Negative CHMP Opinion For Betrixaban In EU - Quick Facts

(RTTNews) - Portola Pharmaceuticals, Inc. (PTLA) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a negative opinion for betrixaban for the prevention of venous thromboembolism in adult patients hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death.

Portola intends to appeal the opinion and seek a re-examination by the CHMP. The MAA for betrixaban included data from pivotal Phase 3 APEX Study.

Betrixaban was approved by the U.S. FDA in June 2017 under the trade name Bevyxxa.

Jack Lawrence, chief medical officer of Portola, said, "The re-examination process allows us the opportunity to address the CHMP's questions and provide further clarification as needed, with the goal of making betrixaban available to acute medically ill patients in Europe who are at risk for VTE."