"Bayer's Troubles Mount: OCEANIC-AF Study Halted, Drug Setback and Restructuring Considered"
Originally Published 2 years ago — by PharmiWeb.com
Bayer's phase III OCEANIC-AF study, comparing asundexian to apixaban in patients with atrial fibrillation at risk for stroke, is being stopped early due to the recommendation of the study's Independent Data Monitoring Committee (IDMC) citing inferior efficacy of asundexian compared to the control arm. Safety data remains consistent with previous reports, and Bayer will analyze the data further. The OCEANIC-STROKE study will continue as planned, and measures will be taken to close the OCEANIC-AF study. Asundexian is an investigational agent and has not been approved for use by any health authority.