Bayer Seeks FDA Approval for MRI Contrast Agent Gadoquatrane

Core Insights - Bayer has submitted a new drug application (NDA) to the FDA for gadoquatrane, a low-dose gadolinium-based contrast agent intended for MRI use in both adults and pediatric patients, including term neonates [1][8] - The proposed dosage of 0.04 mmol gadolinium per kilogram represents a significant reduction of approximately 60% compared to the current standard of care [2][8] - The NDA submission is based on positive results from the pivotal phase III QUANTI studies, which demonstrated the safety and efficacy of gadoquatrane [6][7] Company Developments - Bayer has also submitted a marketing authorization application for gadoquatrane to Japan's Ministry of Health, Labour and Welfare [3] - The QUANTI studies confirmed that gadoquatrane met both primary and secondary efficacy endpoints, improving image quality and aiding in lesion identification during scans [7][8] - The data from the QUANTI Pediatric study indicated that gadoquatrane behaves similarly in children as in adults, with no new safety concerns reported [7][9] Market Context - The demand for medical imaging is increasing due to a rise in chronic diseases such as cancer and heart problems [9] - If approved, gadoquatrane would be the lowest-dose macrocyclic GBCA available in the United States, enhancing Bayer's position in the radiology market [9] - Year to date, Bayer's shares have increased by 58%, significantly outperforming the industry average rise of 2.6% [5]