WAYNE, N.J.—Bayer HealthCare Pharmaceuticals Inc. announcedtoday that its product, Gadavist (gadobutrol), has secured approval from theU.S. Food and Drug Administration. Official FDA approval was given March 14.
Gadavist is a macrocyclic gadolinium-based contrast agent(GBCA), and has been approved for intravenous use in diagnostic magneticresonance imaging (MRI) in adults and children (two years of age and older) todetect and visualize areas with disrupted blood brain barrier and/or abnormalvascularity of the central nervous system (CNS). Gadavist differs from certainother GBCAs in that it is formulated at a higher concentration (1 mmol/mL),compared to 0.5 molar gadolinium-based contrast agents. The higherconcentration leads to half the volume of administration as well as a morecompact contrast bolus.
"The approval of Gadavist enriches our strong portfolioof MRI contrast media," says John Rotondo, Vice President, CommercialOperations, Bayer HealthCare Pharmaceuticals, "and provides a new option forU.S. healthcare providers in contrast-enhanced imaging of the CNS."
According to the U.S. FDA website, Gadavist provides"contrast-enhanced imaging of the central nervous system," which aids in thedetection and visualization of lesions "that disrupt the cell barrier thatnormally separates the brain from the blood stream." Additionally, the siteadds that Gadavist also "helps to detect and visualize abnormal blood supplyand circulation of the central nervous system." Two clinical studies involving657 patients as well as other trial data were conducted to establish the safetyand efficacy of Gadavist.
"Gadavist MRI scans improved the visualization of lesions inthe central nervous system when compared to MRI scans without contrast," saysLibero Marzella, M.D., acting division director, Division of Medical ImagingProducts in the FDA's Center for Drug Evaluation and Research.
The most common side effects reported during the Gadaviststudies were headache and nausea. Hypersensitivity reactions also occurred,according to the FDA website, involving cardiovascular, respiratory or skineffects ranging from mild to severe. All GBCAs, including Gadavist, come with awarning regarding the risk of nephrogenic systemic fibrosis (NSF), a conditionassociated with the use of GBCAs in patients with kidney dysfunction. Gadavistis considered to be one of the GBCAs with a lower risk of NSF.
Outside of the United States, Gadavist is known as Gadovist.The drug is approved in more than 60 countries, and has been in use in Europefor about a year now. According to a January 2010 news release on BayerHealthCare's website, Bayer Schering Pharma AG completed the procedure forsecuring approval for the use of Gadovist 1.0 in children (ages seven andolder) in Europe's main markets in January of last year.
"Our MR contrast agents are some of the most widelyused today, and Bayer is proud to be a world leader in diagnostic imaging,"says Rotondo.
Gadavist is the sixth GBCA to receive FDA approval for usein patients undergoing central nervous system MRIs.