The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
The study evaluated asundexian (50 mg), a once-daily oral anticoagulant candidate, versus placebo—both given alongside standard antiplatelet therapy
These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke
The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke
The development comes as stroke remains one of the world’s biggest health threats
Stroke is the second-leading cause of death and the third-leading cause of disability worldwide
The Pharmaceuticals portfolio and pipeline are more promising than perhaps ever before
Millions of stroke survivors across the world may soon have a new defense
OCEANIC-AF is one trial which evaluates asundexian versus apixaban in patients with atrial fibrillation at risk for stroke within the overall OCEANIC phase III program
Bayer reported the highest market capitalization growth of 23.1% during Q1 2023
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