BOSTON, May 21 /PRNewswire/ — Bayer HealthCare
Pharmaceuticals, Inc. today announced presentation of 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. The results of this
study of this investigational drug met all of its pre-specified
primary efficacy objectives. Gadobutrol is investigational in
the United States and is not
approved by the U.S. Food and Drug Administration.
This phase 3 study had four primary efficacy objectives.
In results comparing unenhanced CNS MRI versus the combined
unenhanced and gadobutrol-enhanced CNS MRI, statistically
significant superiority (P<0.0001) 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 (internal morphology, degree of contrast
enhancement and border delineation). 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.(1)
In the study, 14 subjects (4.1%) reported at least one adverse
event which the investigators considered related to gadobutrol.
No deaths were reported during the study period, and none of
the subjects discontinued from the study due to an AE. One
subject experienced a serious adverse event (SAE), which was not
considered by the investigator to be related to the study drug.
“This was a large mu