FDA panel clears Bayer's MR agent

Image source: Cedars-Sinai Medical Center

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has voted unanimously that clinical trial and post-marketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (Gadovist, Bayer HealthCare Pharmaceuticals), support approval of the product for proposed use in diagnostic 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.

In addition to the vote for approval, committee members concurred by a vote of 15 to one that gadobutrol should be labeled without a nephrogenic systemic fibrosis (NSF) contraindication in the at-risk population.

NSF affects a small percentage of patients with severe renal impairment who undergo contrast-enhanced MRI. All marketed gadolinium-based contrast agents have a boxed warning about the potential for NSF in patients with chronic severe kidney disease or acute kidney injury.

Bayer said 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.

The new drug application (NDA) for gadobutrol was submitted to the FDA on May 14, 2010. The Advisory Committee's recommendations are not binding, but FDA reviewers will consider the panel's recommendation in its final assessment of the NDA.