In pivotal clinical trials evaluating NOACs in patients with NVAF, major bleeding occurred at an annual rate of 3.32% with dabigatran (at the US-approved dose for NVAF), 3.6% with rivaroxaban, 2.13% with apixaban, 2.75% with high-dose edoxaban (60 mg daily), and 1.61% with low-dose edoxaban (30 mg daily).
Data from this part of the study are expected in mid-2015. Jan 15: Portola Pharmaceuticals announced the initiation of a single-arm Phase 4 study to support the approval of andexanet alfa by the US FDA under an accelerated approval pathway.
The open-label, single-arm, Phase 4 study is evaluating andexanet alfa´s ability to decrease anti-Factor Xa activity and restore haemostasis in patients.
It is being conducted over 50 sites in North America and Europe in patients receiving apixaban, rivaroxaban or enoxaparin (a low molecular weight heparin) who present with an acute major bleed, including life-threatening bleeding associated with very low blood counts, or bleeding that occurs in a critical area such as the brain or heart.
The trial excludes bleeding due to major trauma and large blood vessel rupture.
It has been estimated that around 1-4% of pts treated with Factor Xa inhibitors may experience major bleeding and 1% may require emergency surgery.
Development of a specific antidote designed to reverse the anticoagulant activity of Factor Xa inhibitors may provide an important treatment option for pts who experience a major bleeding event or require emergency surgery .The first part of the study is expected to report in Q4 2014 and the second part in early 2015  04.Oct 14: Portola announce that its first of two PIII ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of f XA Inhibitors – Apixaban) studies met its primary and secondary endpoints with high statistical significance.The PIII ANNEXA-A study showed andexanet alfa significantly reduced the level of free unbound apixaban in plasma and restored thrombin generation to normal . It has been estimated that around 1-4% of pts treated with Factor Xa inhibitors may experience major bleeding and 1% may require emergency surgery.Development of a specific antidote designed to reverse the anticoagulant activity of Factor Xa inhibitors may provide an important treatment option for pts who experience a major bleeding event or require emergency surgery . Nov 15: Results of ANNEXA-A and ANNEXA-R (NCT02207725 & NCT02220725) published in the New England Journal of Medicine.In terms of stroke prevention among patients with nonvalvular atrial fibrillation (NVAF), data from clinical trials and meta-analyses suggest that NOACs are as effective as warfarin, and in some cases more effective than warfarin.Tags: Adult Dating, affair dating, sex dating