New Drug Application For Gadoquatrane Accepted For Review In China
Company seeks approval for investigational low dose gadoquatrane for contrast-enhanced magnetic resonance imaging (MRI) of all body regions and the central nervous system (CNS) for adults and pediatric patients including neonates / Submitted dose corresponds to a 60 percent reduction in gadolinium (Gd) compared to standard of care macrocyclic gadolinium-based contrast agents (GBCAs) dosed at 0.1 mmol gadolinium per kilogram of body weight / Applications for marketing authorization in Japan, U.S., EU and other countries already filed, further submissions around the world planned
Bayer today announced that the Center of Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application for gadoquatrane. The investigational contrast agent is intended for contrast enhancement in MRI to detect and visualize known or suspected pathologies in all body regions and the central nervous system in adults and pediatric patients including neonates. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in China. The submitted dose of 0.04 mmol gadolinium per kilogram body weight represents a gadolinium dose reduction of 60 percent compared to the standard of care macrocyclic contrast agents dosed at 0.1 mmol Gd/kg body weight.
“Magnetic resonance imaging is essential for informing and guiding treatment decisions, as evidenced by the increasing number of MRI procedures globally, including China,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. “With this submission, we seek to advance gadoquatrane as a potential low dose contrast agent option for MRI. This commitment aligns with recommendations from radiological societies in addition to European health authority guidance to use the minimum dose necessary to acquire the needed clinical information.”
Patients, particularly those with chronic conditions who need multiple contrast-enhanced MRI scans over their lifetime, can benefit from a reduction in dosage. In China, approximately 16 million contrast-enhanced MRI scans are performed annually, with a growth rate of 15% in recent years.
The submission of gadoquatrane in China is based on positive data from the global pivotal Phase III QUANTI studies, which also included Chinese patients, evaluating the efficacy and safety across a broad range of indications in adult and pediatric patients. Additionally, the healthcare authorities in Japan, the U.S., the European Union and other countries are currently reviewing applications for marketing authorization for gadoquatrane. Further regulatory applications to health authorities worldwide are planned for the coming months.
About the Phase III development program QUANTI
The pivotal QUANTI clinical development program investigated gadoquatrane at a dose of 0.04 mmol Gd/kg body weight. QUANTI 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. In China, 14 sites were included.
In QUANTI CNS and QUANTI OBR, researchers investigated the ability to visualize and detect known or suspected disease on MRI scans using gadoquatrane compared to scans without contrast injection and compared to scans using macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. The 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 and safety profile of gadoquatrane in children is similar to that in adults. The safety events observed with gadoquatrane in the program were similar to those for the comparator macrocyclic gadolinium-based contrast agents with a low incidence of intervention related treatment emergent adverse events and generally consistent with previous data on gadoquatrane and other macrocyclic gadolinium-based contrast agents. No new safety signals were observed.
With first results from the Phase III QUANTI CNS study revealed at the European Congress of Radiology (ECR) in February of this year, further results are planned to be presented at upcoming scientific meetings.
About gadoquatrane
Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI. This low dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.
About MRI
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, characterization, and monitoring of diseases.
About Radiology at Bayer
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 informatics solutions and a medical imaging platform with digital and artificial intelligence (AI) powered applications. In 2024, Bayer’s radiology products generated €2.1B in sales. Bayer continues to advance research and innovation in medical imaging, including the integration of AI.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, visit www.bayer.com and https://pharma.bayer.com.
Source: Bayer