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FDA Approves New Formulation of First Protease Inhibitor Saquinavir

Date: November 7, 1997
Source: Food and Drug Administration (FDA)

FDA is receiving inquiries about Fortovase (saquinavir), a new formulation of a protease inhibitor for HIV infection. The following can be used to answer questions about this product, which was approved on Nov. 7:

Fortovase, a new formulation of Invirase, the first FDA-approved protease inhibitor, comes in a soft gelatin capsule that delivers more drug through the body than its predecessor. Fortovase also stays in the body at increased levels, thus improving treatment.

A controlled clinical study showed that at 16 weeks of treatment, twice as many patients who took Fortovase had undetectable virus levels in the blood compared to those who took Invirase.

Additionally, this is the first HIV drug to be approved since an FDA advisory committee recommended to the agency a more stringent reporting of clinical study results. This approach factors in all patients who start a clinical trial, even those who discontinue using the drug and drop out of the study for any reason. The FDA advisory committee had recommended this type of analysis to give health care providers and people with HIV a more realistic expectation of the efficacy of a given therapy in the clinical setting.

Fortovase is generally well tolerated. The most common adverse effects are gastrointestinal, including diarrhea, nausea and abdominal discomfort. Side effects, for the most part, were similar to Invirase.

Fortovase is taken in 1,200 mg doses, three times a day. Hoffmann-La Roche of Nutley, N.J., manufactures both Invirase and Fortovase.

Food and Drug Administration U.S. Department of Health and Human Services Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.