|  |
|
|
|
|
|
J&J curbs expanded Reminyl use
Nieuws van: MarketWatch
Shares of J&J (JNJ: news, chart, profile) dipped 1 percent to $61.85 by the close of trading Friday.
The drugmaker said it is discussing the findings with regulatory authorities, including the U.S. Food and Drug Administration, said J&J spokeswoman Carol Goodrich.
The New Brunswick, N.J.-based company's pharmaceutical research and development subsidiary said it had been conducting the studies to test Reminyl as a treatment for mild cognitive impairment.
Goodrich added that company would continue to promote the Alzheimer's therapy for its FDA-approved use. Reminyl is approved in 69 countries to treat mild-to-moderate Alzheimer's disease.
"We've never seen that [safety] signal before in any of the Alzheimer's trials of Reminyl," she said.
In a pair of trials enrolling about 2,000 patients, 15 deaths from various causes occurred in patients taking Reminyl compared with five deaths in patients using a placebo, J&J said.
J&J gave the study results to the trade group Pharmaceutical Research and Manufacturers of America this week for publication in the group's clinical trial database, Goodrich said.
The database is a voluntary industry initiative to publish the results of both favorable and unfavorable studies of drugs to alert patients and doctors to uses of a drug that may be ineffective or unsafe.
The data will also be submitted to peer-reviewed medical journals for publication and posted on the Web sites of regulatory authorities in Europe and Canada, she said.
www.marketwatch.com/...%7B08D53A81%2D2205%2D4916%2DACDF%2DD2BC8054C1FA%7D - 21 Jan 2005
|
|
|
|
Printen
Doorsturen