Portola fails to convince EMA that betrixaban is ready for prevention of certain venous thromboembolism in adult patients

Portola will need to provide further clarification to the European Medicines Agency (EMA) for making betrixaban available for the prevention the VTE in adult patients, who also risk from VTE-related death who are at risk for venous thromboembolism, as the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion it.

Portola said on Friday in a press release it will appeal the opinion and seek a re-examination by the CHMP, saying it believes to have generated substantial evidence which demonstrates the clinically-meaningful benefit of betrixaban in reducing VTE and VTE-related deaths in this vulnerable patient population.

“We remain confident in its potential to have a major public health impact,” said Jack Lawrence, chief medical officer of Portola.

He said that the re-examination process allows the company to address the CHMP’s questions and provide further clarification as needed.

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 Marketing Authorization Application (MAA) for betrixaban included data from Portola’s pivotal Phase 3 APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide, Portola said in its press release. It added that the APEX study evaluated oral betrixaban from hospital admission to home (35 to 42 days) compared with injectable enoxaparin for 6 to 14 days followed by placebo in assessing the prevention of VTE in high-risk acutely ill medical patients.

The company reminded that betrixaban was approved by the U.S. Food and Drug Administration in June 2017 under the trade name Bevyxxa.

According to certain data, in 2007, over 500,000 deaths in the EU were associated with an estimated 1.1 million venous thromboembolic events – approximately one-third of these events manifested as PE.