Drugmaker Boehringer Ingelheim has applied with the Food and Drug Administration for approval of its experimental HIV protease inhibitor tipranavir, the company announced Monday. The drug also was submitted for marketing approval in the European Union. Tipranavir, if approved, would be the only nonpeptidic protease inhibitor available. Clinical trials have shown that because of its unique chemical makeup and resistance profile, tipranavir is useful in treating protease inhibitor-resistant stains of the virus. Studies also have shown the drug may be less likely to boost blood-based cholesterol and triglyceride levels than other protease inhibitors.
Boehringer Ingelheim is seeking an accelerated review status from the FDA, which could result in a marketing decision within six months. A company spokesperson says the drug, which does not yet have a brand name, may be available as early as the middle of 2005. Tipranavir is designed to be taken with a booster dose of the protease inhibitor Norvir. Norvir's maker, Abbott Laboratories, in December 2004 boosted the price of that drug by 400%. Company officials said the price increase was made to better reflect the growing use of low-dose Norvir therapy to boost the effectiveness of other protease inhibitors.