The first non-nucleoside reverse transcriptase inhibitor is heading for approval in its first world market, the USA. On June 7, the US Food and Drug Administration's Antiviral Drugs Advisory Committee determined that Boehringer Ingelheim's Viramune (nevirapine) should go into the accelerated approval process, with a broad-ranging indication.
The panel decided that Boehringer's proposed indication for use in combination with nucleoside analogs for treatment of patients with HIV infection who have experienced clinical or immunological deterioration should be broadened. They concluded that nevirapine should be used earlier on in the course of the disease. However, they did caution against adding the drug as a single-agent in a failing patient, noting it would be preferable if the drug was added with at least one nucleoside analog to which a patient had not previously been exposed.
A key attraction of the new compound, said the panel, was its potential role in combination regimens in patients who exhibit resistance to the new protease inhibitor drugs. The panel recommended that Boehringer conduct drug interaction studies as soon as possible to determine the best combinations to use.
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