Nevirapine Gains Fast-Track Approval In USA For HIV

Boehringer Ingelheim has been granted approval in the USA to market its non-nucleoside reverse transcriptase inhibitor Viramune (nevirapine) for use in combination with nucleoside analogs for the treatment of patients with HIV-1 infection who have experienced clinical and/or immunological deterioration. The labeling for the drug notes that resistance emerges rapidly when nevirapine is used as a monotherapy and that this should be avoided.

The approval was granted under the accelerated review procedure, which allows the company to market the drug on the basis of its activity on surrogate endpoints, in parallel to conducting clinical endpoint studies looking at, for example, the incidence of opportunistic infections and survival. Boehringer is conducting two Phase III studies which will have survival and time to AIDS progression as primary endpoints (see later).

Launch In August? Viramune is the first non-nucleoside RTI to be approved for marketing, and Boehringer hopes to launch the product in August, after it has scaled up its production process to cope with the anticipated demand. The company filed for approval to market nevirapine on February 23, so the review was accomplished in just four months.