Bayer announced that the Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates.
The approval was based on data from two Phase 3, multicenter, open-label clinical trials: the GEMSAV (n=457) study in patients with known or suspected vascular disease of the supra-aortic arteries, and the GRAMS (n=292) study in patients with known or suspected renal artery disease. For both studies, Gadavist met the primary objective of superior assessability and noninferior sensitivity and specificity vs. non-contrast MRA. The data showed gadobutrol-enhanced MRA had statistically significant higher assessability (visualization) vs. non-contrast MRA images.
Gadavist injection was initially approved in March 2011 for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and pediatric patients aged ≥2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Then in June 2014, Gadavist was approved for MRI of the breast to assess the presence and extent of malignant breast disease, and in December 2014 for pediatric patients <2 years old (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
Gadavist is available in a 604.72mg/mL strength as 2mL, 7.5mL, 10mL, and 15mL single-dose vials and as 7.5mL, 10mL, and 15mL single-dose prefilled syringes.
For more information call (888) 842-2937 or visit Gadavist.com.