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news.Bayer HealthCare Pharmaceuticals has presented data in a poster titled 'Results from a multicenter, open-label Phase 3 study to determine the safety and efficacy of gadobutrol, a macrocyclic 1.0 molar GBCA in patients referred for contrast-enhanced MRI of the central nervous system (CNS),' at the 48th Annual Meeting of the American Society of Neuroradiology (ASNR) in Boston, MA.
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Bayer HealthCare said that the results of the study of investigational drug gadobutrol met all of its pre-specified primary efficacy objectives. Gadobutrol is investigational in the US and is not approved by the FDA.
Bayer HealthCare’s gadobutrol phase 3 study had four primary efficacy objectives. In results comparing unenhanced CNS MRI versus the combined unenhanced and gadobutrol-enhanced CNS MRI, statistical superiority of gadobutrol images compared to unenhanced images was shown for all three individual blinded readers as well as the average blinded reader for three of the primary efficacy variables. Non-inferiority was the objective for the number of lesions detected in this study and was demonstrated for two of three blinded readers, as well as the average of the blinded readers.
Juan Gutierrez, assistant professor of radiology, neuroradiology section and director of clinical trials division at the University of Texas Health Science Center at San Antonio, said: “This was a multicenter study that included patients referred to contrast-enhanced MRI of the central nervous system based on clinical symptoms and results from previous procedures.”
Thomas Balzer, vice president of global clinical development of diagnostic imaging at Bayer HealthCare, said: “The results from this Phase 3 study are important in our overall development program and in our approach to gain regulatory approval for Gadobutrol in the US.”