Bayer AG BAYRY BAYZF stopped the OCEANIC-AF Phase 3 study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke.
The decision is based on the study’s Independent Data Monitoring Committee (IDMC) recommendation as part of ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm.
Bristol-Myers Squibb Company BMY and Pfizer Inc’s PFE apixaban is sold under the Eliquis brand.
Bayer will further analyze the data to understand the outcome and publish the data.
Though the OCEANIC-AF was stopped early, the IDMC recommends continuing investigating asundexian in the OCEANIC-STROKE phase 3 study as planned.
Bayer plans to analyze the data to understand why asundexian underperformed and is reevaluating the design of another phase 3 trial, the OCEANIC-AFINA Phase 3 study, in light of the setback.
Separately, a Missouri jury reportedly ordered Bayer to pay $1.56 billion to four plaintiffs due to injuries allegedly caused by Roundup weedkiller, potentially escalating pressure on the company to change its legal approach.
The jury found Bayer’s Monsanto responsible for negligence, design flaws, and failure to warn about Roundup’s risks, awarding compensatory and punitive damages totaling $61.1 million and $500 million per plaintiff, respectively, Reuters reported.
Despite settling most Roundup cases in 2020 for up to $10.9 billion, around 50,000 claims persist among 165,000 alleging Roundup-related injuries following Bayer’s acquisition of Monsanto.
Photo Via Company
Read full article here