An FDA expert panel has provided an important endorsement for Merck's experimental AIDS drug Isentress. The twice-a-day pill is the first in a new class of AIDS drugs. If fully approved by the agency, it would be added to the currently available drug "cocktails" for use among patients who have developed resistance to the HIV drugs already on the market. But some of the experts voiced their concerns at the high rate of cancer developed by trial participants. They're worried that the same trends would apply to the broader population of patients taking the drug, and may warrant restricting the drug's use to patients who have failed multiple therapies.
- check out this release [1]Â on the vote
Related Articles:
FDA: Merck's anti-HIV drug hopeful. Report [2]
FDA priority review granted for Merck's Isentress. Report [3]
Brazil threatens to break Merck AIDS drug copyright. Report [4]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-fda-advisory-committee-unanimously-recommends-accelerated-approval-isen
[2] http://www.fiercepharma.com/story/fda-mercks-anti-hiv-drug-hopeful/2007-08-31?utm_medium=rss&utm_source=rss
[3] http://www.fiercebiotech.com/node/7416
[4] http://www.fiercebiotech.com/story/brazil-threatens-to-break-merck-aids-drug-copyright/2007-05-07