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On Thursday, the Cellular, Tissue, and Gene Therapies Advisory Committee will discuss AstraZeneca Plc’s (NASDAQ:AZN) supplemental biologics license application for Andexxa (coagulation factor Xa (recombinant), inactivated -zhzo), for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The FDA initially granted accelerated approval of Andexxa, a recombinant modified human factor Xa (FXa) protein, in 2018 based on the change from baseline in anti-activated FXa (anti-FXa) activity, as a surrogate endpoint reasonably likely to predict clinical benefit as provided for in 21 CFR 601.41.
AstraZeneca was required to conduct a randomized controlled trial to verify and describe the clinical benefit of Andexxa, due to uncertainty as to the relation of the surrogate endpoint to clinical benefit and the observed clinical benefit to ultimate outcomes in the indicated population. In January 2024, ...
