Advisors: New HIV Drug Merits Quick Approval
Posted by pozlife on September 6, 2007
by The Associated Press
Posted: September 5, 2007 – 5:00 pm ET
(Washington) An experimental 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 anti-retroviral 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.
Isentress is meant to be used as part of a “cocktail” of drugs to fight HIV in patients who have developed a resistance to older medications. HIV – the human immunodeficiency virus – causes AIDS.
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.