Portola expects CHMP to recommend andexanet alfa, but not betrixaban

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EMA's CHMP communicated a "positive trend vote" for an MAA for AndexXa andexanet alfa (IndexXa, PRT4445, PRT064445) to reverse the anticoagulant effects of Factor Xa inhibitors. However, Portola said the committee requested additional data, which could delay the CHMP opinion on the andexanet alfa MAA to 4Q18, but did not disclose details.

The company also said CHMP communicated a "negative trend vote" for an MAA for its Bevyxxa betrixaban (PRT054021) to prevent venous thromboembolism (VTE) in hospitalized and post-discharge adults with acute illnesses who are at high risk for complications...