The FDA has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.
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Portola Pharmaceuticals announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for its investigational agent andexanet alfa, as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled bleeding event or who require urgent or emergency surgery. There is currently no…
Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.
Portola Pharmaceuticals, Bristol-Myers Squibb Company, and Pfizer announced results from the Phase 3 ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors – Apixaban) study with andexanet alfa as a reversal agent for Eliquis (apixaban).
Bristol-Myers Squibb and Pfizer announced results from the pre-specified secondary analysis of the Phase 3 AMPLIFY-EXT trial with Eliquis (apixaban).
Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) vs. warfarin to blood pressure control in patients with nonvalvular atrial fibrillation (NVAF).
Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial according to patient age in patients with nonvalvular atrial fibrillation (NVAF).
The FDA has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban; Bristol-Myers Squibb Company and Pfizer) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE.
The FDA has accepted Bristol-Myers Squibb’s and Pfizer’s supplemental New Drug Application for Eliquis (apixaban), an oral direct Factor Xa inhibitor for prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery.
Bristol-Myers Squibb and Pfizer announced results from a six month Phase 3 AMPLIFY trial in patients with acute venous thromboembolism who received Eliquis (apixaban) or the current standard of care, parenteral enoxaparin treatment overlapped by warfarin therapy.