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Bayer's Low-Dose Contrast Agent Gadoquatrane Steps Closer to Approval in Major Markets
Bayer Pharmaceuticals' low-dose contrast agent, Gadoquatrane, is making significant strides towards regulatory approval in key global markets. The company's application for the agent has been accepted for review by the regulatory authorities in China, the United States (FDA), Japan, and the European Union.
The Center for Drug Evaluation in China and the US FDA have officially accepted Bayer's application for examination. This acceptance follows Bayer's receipt of approval from the US health authority, FDA, in late August. The company has already submitted applications for approval of Gadoquatrane in Japan, the EU, and the USA.
Dr. Konstanze Diefenbach, Head of Research and Development in Radiology at Bayer Pharmaceuticals, commented on the submission, stating that this is a crucial step in offering a low-dose option for MRI to patients and their treating physicians in China. Diefenbach also mentioned that the increasing number of MRI procedures worldwide, including China, underscores the importance of magnetic resonance imaging in supporting treatment decisions for patients.
The positive data from the Phase-3 QUANTI studies, which included Chinese patients, provide a strong foundation for the approval process of Gadoquatrane. Diefenbach stated that the submission aligns with recommendations from radiological societies and European health authorities to use the lowest possible dose to obtain necessary clinical information.
Bayer aims to initiate the approval process for Gadoquatrane in other regions of the world, supported by positive data from the Phase-3 QUANTI studies. Gadoquatrane is a low-dose contrast agent currently under development by Bayer, which, if approved, could offer a significant advancement in MRI procedures worldwide.
