UPDATE 1-US FDA panel recommends Merck AIDS drug
SILVER SPRING, Md., Sept 5 (Reuters) - Merck & Co Inc's (MRK.N: Quote, Profile, Research) experimental AIDS drug Isentress merits approval, a panel of expert advisers to the U.S. Food and Drug Administration said on Wednesday. The advisory panel voted unanimously to recommend marketing approval for the twice-a-day pill, known generically as raltegravir, the first in a novel class of AIDS treatments to go before regulators.
Panel members were continuing to discuss the recommended label and the appropriate patient population for the drug, given certain risks that include an increased incidence of cancer in treated patients.
The FDA will make the final decision on approval, but usually follows the advice of its expert panels.
The drug was tested in patients who have become highly resistant to current HIV medicines. Resistance is a problem as the human immunodeficiency virus (HIV) that causes AIDS can mutate, particularly if patients fail to rigorously follow complicated regimes.
One worrisome trend discussed at length at the panel meeting is the higher cancer rate in patients treated with the Merck drug. Twenty malignancies were seen in the Merck group, compared with one malignancy within control groups, according to FDA data.
"There is no doubt that this is a great drug, absolutely, and it's very useful for patients who've experienced lots of failure. That's not the issue," Peter Havens, professor of pediatrics and epidemiology at Medical College of Wisconsin, said.
If there is "significant potential risk, then expanding the population, without thinking about it, is potentially very dangerous," he said during the panel meeting.
Havens is one of several panel members who urged the FDA to limit the labeling to patients who have failed multiple types of therapies, rather than the broader "treatment experienced," requested by Merck.
(Reporting by Kim Dixon)
((Editing by Tim Dobbyn/Jeffrey Benkoe; Reuters Messaging; email@example.com; email; firstname.lastname@example.org, 1-202 354 5848)) Keywords: MERCK FDA/
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作者:admin@医学,生命科学 2011-10-19 17:49