Posted by Michael Wonder on 02 Jan 2019
U.S. FDA approves Portola Pharmaceuticals’ prior approval supplement for Andexxa Generation 2 manufacturing process
31 December 2018 - Expands patient access to Andexxa, the first and only antidote for reversal of the Factor Xa inhibitors rivaroxaban or apixaban.
Portola Pharmaceuticals today announced that the U.S. FDA has approved the Company’s prior approval supplement for its large-scale, second generation Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], allowing for broad commercial launch in the United States.
Andexxa received both U.S. orphan drug and FDA breakthrough therapy designations and was initially approved on May 3, 2018 under the FDA's accelerated approval pathway.
