Roche Files For New Invirase Formulation

Roche has filed a New Drug Application in the USA for a new soft gelatinformulation of its HIV protease inhibitor saquinavir, which provides eight to nine times the drug exposure of the current formulation. The company is seeking approval of the drug in combination with other antiretrovirals.

Saquinavir was the first HIV protease inhibitor to reach the market, but the current hard gelatin formulation has suffered from poor absorption. The new soft gelatin form contains twice the amount of active drug compared to the old form (1,200mg rather than 600mg).

Roche has submitted the results of two dose-ranging and safety trials in support of the NDA, and a third study comparing the activity and safety of the old and new forms will be submitted to the Food and Drug Administration in the summer, during the review process.