Portola Pharmaceuticals Announces Results of CHMP Oral Explanations for Andexanet Alfa and Betrixaban

Portola Pharmaceuticals (Nasdaq:PTLA) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorisation Application (MAA) for andexanet alfa, a Factor Xa-inhibitor reversal agent, and a negative trend vote for betrixaban, an oral, once-daily Factor Xa inhibitor.

As quoted in the press release:

“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 Bill Lis, chief executive officer of Portola. “The Committee has requested additional data, which could delay the CHMP opinion until the fourth quarter, but we will be working with the CHMP in the coming weeks to further clarify their request and the impact on timing. In the meantime, we look forward to presenting important new data from the ANNEXA-4 trial during  a late-breaker session at next month’s American College of Cardiology meeting.”

Click here to read the full press release.