FDA panel backs Bayer imaging drug
WASHINGTON (Reuters) - U.S. advisers on Friday recommended approval of a Bayer AG imaging drug for use with magnetic resonance imaging scans of the central nervous system.
A Food and Drug Administration advisory panel voted 16-0 in favor of the drug, gadobutrol. The FDA usually follows panel recommendations. A final decision is due by March 14.
Gadobutrol is a stronger version of products in a class called gadolinium-based contrast agents, or GBCAs, used with MRI scans. The drugs carry warnings about the risk of nephrogenic systemic fibrosis (NSF), a potentially fatal skin disorder.
GBCAs with higher NSF risk come with a strong warning that they should not be used in patients with kidney disease, which increases the chances of the skin disorder.
The FDA panel voted 15-1 that gadobutrol did not need the strongest warning against use in kidney disease patients. FDA reviewers said the Bayer drug appeared to carry a lower NSF risk. The lower-risk drugs include an NSF warning, but do not recommend against all uses in kidney disease patients.
The higher-risk GBCAs are Bayer's Magnevist, Covidien Public Ltd Co's Optimark and Omniscan, made by General Electric Co's healthcare division.
Bayer has reported 10 NSF cases since gadobutrol was approved in Europe in 1998. Two patients received only gadobutrol, while the others also were given another GBCA. About 5 million patients have been exposed to gadobutrol, which is sold under the name Gadovist.
FDA staff raised concern patients may receive accidental overdoses of gadobutrol because the drug is twice the strength of similar approved drugs. Bayer said it would prominently display the higher strength on gadobutrol's label and take other steps to help prevent overdoses.
The company's shares gained 0.09 percent in German trading.