AGC Biologics will supply bulk drug substance for the launch of Portola Pharmaceuticals' Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was recently approved under the FDA's Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.
AGC Biologics is presently manufacturing bulk drug substance for Portola's planned launch of Andexxa.
"We are extremely pleased to have had the opportunity to help Portola provide this unique antidote for rivaroxaban- and apixaban-treated patients with life threatening or uncontrolled bleeding," said Gustavo Mahler, Ph.D., President & Chief Executive Officer of AGC Biologics. "Our facilities in the United States, Denmark and Japan enable us to provide unique and robust manufacturing solutions to bring products to market globally. As with Portola, our commitment to deliver marketed products is prioritized across our entire organization."