Bayer’s plans to make Asundexian into a 5 billion euro per year product have faced a setback. The drug showed “inferior efficacy” compared to Eliquis by Bristol Myers Squibb and Pfizer in a phase 3 trial. This resulted in Bayer halting the study early, but the company continues to pursue the drug’s testing in another indication. Previously, asundexian failed to outperform a placebo in mid-phase trials in patients recovering from heart attacks and a certain type of stroke. It also underperformed in a late-stage trial involving atrial fibrillation patients. The company is currently reevaluating the design of another phase 3 trial (OCEANIC-AFINA) but continues to test the drug in a third phase 3 trial (OCEANIC-STROKE). The failure of OCEANIC-AF induces uncertainty about the future success of asundexian.
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[Source: Fierce Biotech, November 20th, 2023]