Roche submits FDA application for new formulation of Invirase

Roche on Monday announced it has submitted a New Drug Application to the Food and Drug Administration for a new 500-milligram formulation of its HIV protease inhibitor Invirase. If approved, the new formulation would reduce pill count for the drug by more than half, from five pills to two taken twice daily. The FDA approved Invirase in 2003 for use at 1,000 milligrams daily in combination with a 100-milligram booster dose of Norvir and other anti-HIV medications. "It is important to develop anti-HIV therapies that are not only potent and well-tolerated but will improve convenience for patients and help to maximize adherence to a treatment regimen," said Nicholas Bellos of Southwest Infectious Disease Associates in Dallas. "The new formulation of Invirase will provide significantly reduced pill count to patients, with continuing potency and a well-characterized safety profile." A filing for approval to market the new formulation in the European Union is expected in the next few days.