FDA Advisory Committee Recommends Approval of Bayer's Gadobutrol Injection for MRI of the Central Nervous System

WAYNE, N.J., Jan. 21, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously that clinical trial and postmarketing 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 (2 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 1 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.

Gadobutrol is formulated at a 1.0 molar concentration (mol/L) which provides a higher concentration (lower volume) compared to other contrast agents used for CNS imaging. Bayer 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.

"Bayer is pleased that the Advisory Committee recognized the totality of the clinical and post-marketing data presented today," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "If approved by the FDA, Bayer believes that gadobutrol will provide healthcare providers with an additional new option for CNS imaging in the United States."

source: PR Newswire

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