Portola gains next-generation Andexxa approval, aims for wider U.S. launch

FDA approved a Prior Approval Supplement for Andexxa recombinant coagulation factor Xa inactivated-zhzo (formerly andexanet alfa) to be manufactured with a second generation process, which Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said will support a broader launch of the agent.

In May, FDA granted accelerated approval to the modified human Factor Xa protein to reverse the anticoagulant activity of Factor Xa inhibitors Xarelto rivaroxaban and Eliquis apixaban in patients with life-threatening or uncontrolled bleeding (see "FDA Approves Portola's Andexxa")...