Portola Pharma files U.S. application for Gen 2 Andexxa manufacturing process; shares up 2% premarket

Portola Pharmaceuticals (NASDAQ:PTLA) is up 2% premarket on light volume on the heels of its announcement that it has submitted a prior approval supplement (PAS) to the FDA seeking sign-off on its large-scale Generation 2 manufacturing process for anticoagulant reversal agent Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo). The company says the PAS will allow for the broad commercial launch of the product in the U.S. The FDA should make its decision no later than Q1 2019.

In Europe, Portola says the advisory group CHMP should render an opinion on approval next quarter and, if positive, market approval will follow in Q1 2019.