AGC Biologics nabs contract to produce anticoagulant reversal agent AndexXa

US clinical and commercial manufacturing of therapeutic proteins company AGC Biologics, says that it will supply bulk drug substance for the launch of 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, developed by USA based Portola Pharmaceuticals (Nasdaq: PTLA), received both US Food and Drug Administration Orphan Drug and 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. Portola’s shares edged up 1.3% to $40.01 by close of trading on Thursday, following the announcement.

First launches expected in early June