Bayer announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates. The submitted dose is 0.04 mmol gadolinium per kilogram body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., corresponding to a 60% reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
The submission of gadoquatrane to the US FDA is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients globally. The first results from the Phase III QUANTI CNS study were presented at the European Congress of Radiology (ECR) in February of this year and further results are planned to be presented at upcoming scientific meetings. Nearly 40 million MRI scans are performed each year in the United States.
Bayer recently announced the submission of gadoquatran to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, marking the first application for marketing authorization for the investigational contrast agent. Further regulatory applications to health authorities worldwide are planned for the coming months. The pivotal QUANTI clinical development program investigated gadoquatrane at a dose of 0.04 mmol Gd/kg bodyweight, which represents a 60% lower gadolinium dose compared to macrocyclic contrast agents dosed at 0.1mmol Gd/kg body weight; Submitted dose corresponds to a 60% reduction in gadolinium compared to macrocyclic contrast agent dosed at 0.1 mmol Gd/kg bodyweight.
The pivotal QUANTIclinical development program investigated gadoqu at a dose of 0.4 mmol Gd/kg body body weight, which represents a 60% low gadolinium dose compared to microcyclic contrast agents dosed At 0.1 mmol GD/kg body weight. QANTI consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies - QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) - as well as the QUANTI Pediatric study. In total, 808 patients in 15 countries participated in the program.
The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane In children is similar to that in adults. The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs.
No new safety signals were observed. With an estimated 65 million procedures performed annually worldwide, contrast-enhanced MRI plays a key role in the healthcare continuum. MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues.
This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET).
Bayer's comprehensive offerings also include formatics solutions and a medical imaging platform with digital and artificial intelligence (PET). Bayer's comprehensive solutions and a medical imaging platform With digital and artificial intelligence (PIT). Bayer's comprehensive offerings also includes digital and artificial intelligence (P).
