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FDA panel backs Merck HIV drug

The FDA's Antiviral Drugs Advisory Committee backs accelerated approval of Merck's Isentress

The FDA's Antiviral Drugs Advisory Committee on 5 September unanimously backed accelerated approval of Merck's Isentress, a treatment for HIV patients whose disease has progressed in spite of therapy with other drugs.

The panel, made up of outside experts from a number of fields, recommended that the FDA approve Isentress for use in combination with other antiretroviral therapies for the treatment of HIV patients who experience viral replication despite treatment with other drugs. The FDA is not required to follow the recommendations of its advisory panels, but it generally does so.

Isentress, also known by the chemical name raltegravir, appears poised to be the first approved drug in a new class of antiretroviral agents called integrase inhibitors. The drug works by blocking the viral integrase enzyme, which is responsible for inserting HIV DNA into human DNA.

Merck said it expects action from the FDA on its marketing application for the drug by the middle of next month. The accelerated approval that the panel recommended would allow the product to be approved based on surrogate endpoints from clinical trials rather than on clinical outcomes. Surrogate endpoints are markers such as laboratory measurements that are assumed to predict a positive clinical outcome that it could take years to measure.

If accelerated approval is granted, it will almost certainly come with the stipulation that Merck must complete years' worth of post-marketing safety and efficacy studies, with the eventual goal of documenting clinical outcomes.

The advisory panel made its positive recommendation for Isentress based on data from studies in which the drug was administered to HIV-infected patients who had failed antiretroviral therapies and whose disease was resistant to at least one drug in each of three classes of oral antiretroviral therapies.

Phase III data released by the company early this year showed that Isentress used in combination with other AIDS drugs for 16 weeks reduced viral load to nearly undetectable levels in about 80 per cent of patients who had previously failed antiretroviral therapy.

The FDA accepted Merck's New Drug Application for Isentress in late June, granting the drug priority review status, under which the agency is required to act on the NDA within six months of its submission. Priority review is reserved for products that address unmet medical needs.

Isentress is already available to many patients through a global expanded access clinical research programme called EARMRK, which offers the drug free of charge. Merck is also working to get the drug approved by regulatory agencies in a number of countries outside the US.

30th September 2008

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