Bayer seeks EMA nod for Gadoquatrane
Berlin: Bayer has announced the submission of a marketing authorization application to the European Medicines Agency (EMA) for its investigational contrast agent gadoquatrane for contrast enhancement in magnetic resonance imaging to detect and visualize known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients including neonates.
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. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the European Union.
“With this submission, Bayer is seeking to offer a low dose option for patients and their treating physicians in the EU,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development, Bayer. “This commitment aligns with recommendations from health authorities and guidelines from scientific bodies in Europe and beyond, which recommend using 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.”
An estimated 16 million contrast-enhanced MRI scans are conducted annually within the European Union. Over the past five years, the number of contrast-enhanced MRI procedures has experienced an annual growth rate of around 5 percent there.
The submission of gadoquatrane to the European Medicines Agency is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane across a broad range of indications in adult and pediatric patients globally.
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.
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 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 observed 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.
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.
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.
