Portola Pharmaceuticals Receives and Plans to Appeal Negative CHMP Opinion Regarding Marketing Authorization for Betrixaban in the European Union

Portola Pharmaceuticals (Nasdaq:PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for betrixaban for the prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death. The Company intends to appeal the opinion and seek a re-examination by the CHMP.

As quoted in the press release:

“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,” said Jack Lawrence, M.D., chief medical officer of Portola. “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.”

Click here to read the full press release.