Gadavist Approved for MRI of the CNS

Bayer HealthCare announced that Gadavist (gadobutrol injection), a macrocyclic gadolinium-based contrast agent, has been approved for intravenous use in diagnostic magnetic resonance imaging (MRI) in patients ≥2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the CNS. This approval was based on data from two clinical studies that demonstrated that Gadavist provided a statistically significant improvement for contrast enhancement and border delineation using a scale of 0–4, and for internal morphology using a scale of 0–3. For both studies, the improvement of visualization endpoints in paired Gadavist images compared to precontrast images resulted in improved assessment of normal and abnormal CNS anatomy.

Gadavist is formulated at a higher concentration of 1mmol/mL. Compared to 0.5 molar gadolinium-based contrast agents, the higher concentration of Gadavist results in half the volume of administration.  

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