European Regulators Nix Portola’s Factor Xa Inhibitor Betrixaban

Unlike the US FDA, the European Medicines Agency has recommended against the drug’s commercialization. The company plans to appeal.

European Regulators Nix Portola’s Factor Xa Inhibitor Betrixaban

Portola Pharmaceuticals has some work to do if it wants to see its oral factor Xa inhibitor betrixaban (Bevyxxa) approved for prevention of venous thromboembolism (VTE) in Europe, after a European Medicine Agency (EMA) committee recommended against marketing authorization on Thursday.

The company has been seeking approval of the drug for the prevention of VTE in adults hospitalized for an acute medical illness who have risk factors for VTE, with supporting evidence from the APEX trial, which missed its primary endpoint but provided results suggestive of a benefit. The US Food and Drug Administration considered the data and approved betrixaban in June 2017.

The EMA’s Committee for Medicinal Products for Human Use, however, concluded this week that the benefits of using betrixaban in this setting did not outweigh the risks, highlighting the increased risk of bleeding compared with standard-of-care enoxaparin.

Portola may request reexamination of the opinion within 15 days, and the company said in a press release that it plans to do so.

“We believe we have generated substantial evidence which demonstrates the clinically meaningful benefit of betrixaban in reducing VTE and VTE-related deaths in this vulnerable patient population, and we remain confident in its potential to have a major public health impact,” Jack Lawrence, MD, chief medical officer of Portola, said in the press release.

Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …

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