HIV drug from Merck & Co. Inc. should be quickly
approved for use by patients running out of treatment
options, federal advisers recommended Wednesday.
The panel of
outside experts agreed unanimously that available data
support accelerated approval of Isentress, also known as
raltegravir, by the Food and Drug Administration.
The FDA isn't
required to follow the advice of its outside advisory
panels but does so most of the time. Merck expects an agency
decision by mid-October. If approved, Isentress would
be the first in a new class of antiretroviral drugs
called integrase inhibitors.
The Merck drug
targets integrase, one of three enzymes used by the virus
to replicate and infect cells. The FDA previously has
approved drugs that target the two other enzymes,
protease and reverse transcriptase.
meant to be used as part of a ''cocktail'' of drugs to fight
HIV in patients who have developed a resistance to older
Last month, the
FDA approved another novel HIV drug, Pfizer Inc.'s
Selzentry. That drug is the first that works by blocking a
crucial doorway, called the CCR5 receptor, that HIV
often uses to enter white blood cells. (AP)