FDA Rejects Portola Pharma Factor Xa Antidote

Aug. 19, 2016

Portola Pharmaceuticals said that the FDA has issued a Complete Response Letter rejecting its application of andexanet alfa, AndexXa, the company's Factor Xa antidote.

According to the San Francisco-based biotech, the FDA rejected AndexXa's approval based on questions associated with AndexXa's manufacturing and its efficacy and safety in drugs other than J&J's Xarelto and BMS/Pfizer's Eliquis. The FDA also indicated that it needs more time to review documents recently submitted by Portola.

Portola developed AndexXa to reverse the anticoagulant effects of factor Xa inhibitors. The absence of an antidote that can reverse the anticoagulant effects of Factor Xa inhibitors has kept the treatment from being used in certain patient groups. In order to broaden the use of their drugs, J&J, BMS, and Pfizer provided funding to Portola Pharmaceuticals so it could develop AndexXa.

Read the press release