* FDA to make final decision by March 14
* Bayer shares gain slightly
(Adds company comment in paragraph 8)
WASHINGTON Jan 21 U.S. advisers on Friday
recommended approval of a Bayer AG (BAYGn.DE) drug for use with
magnetic resonance imaging scans of the central nervous
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 to help
make MRI scans easier to read. The intravenous drugs carry
warnings about the risk of nephrogenic systemic fibrosis (NSF),
a rare but 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 COV.N Optimark, and Omniscan, made by General
Electric Co's (GE.N) healthcare division.
Bayer has reported 10 NSF cases since gadobutrol was
approved in Europe in 1998. Two patients received only
gadobutrol, while the others were also given another GBCA.
About 5 million patients have been exposed to gadobutrol, which
is sold under the name Gadovist.
Bayer said two studies confirmed the drug was safe and
effective. "Bayer is pleased that the advisory committee
recognized the totality of the clinical and post-marketing
data," Pamela Cyrus, head of U.S. medical affairs for Bayer
HealthCare Pharmaceuticals, said in a statement.
FDA staff raised concern that patients might 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 trading in
(Reporting by Lisa Richwine; editing by Gerald E. McCormick
and Andre Grenon)