Bayer's imaging agent gadobutrol backed by US FDA advisory committee

German drug major Bayer’s (BAY: DE) US subsidiary says that the Peripheral and Central Nervous System Drugs Advisory Committee to the Food and Drug Administration has voted unanimously that clinical trial and post-marketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children (two years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).

In addition to the vote for approval, Committee members concurred by a vote of 15 to one that gadobutrol should be labeled without an NSF (nephrogenic systemic fibrosis) contraindication in the at-risk population. NSF is a very rare but serious disease that affects a small percentage of patients with severe renal impairment who undergo contrast-enhanced MRI. All marketed GBCAs have a boxed warning about the potential for NSF in patients with chronic severe kidney disease or acute kidney injury.

Bayer says it appreciates the Committee's discussion and suggestions around risk minimization for inadvertent dose misadministration and will continue to work with the FDA as it finalizes its review of gadobutrol.