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Friday November 7 6:08 PM EST
FDA approves Roche drug for AIDS virus
WASHINGTON, Nov 7 (Reuters) - The U.S. Food and Drug Administration on Friday approved Hoffman-La Roche's Fortovase (saquinavir) for treatment of HIV, the virus that causes AIDS.
The FDA announced the approval in a statement.
Fortovase is a new formulation of Invirase, another protease inhibitor manufactured by Hoffman-La Roche. It comes in a soft gelatin capsule that delivers more drug than Invirase, and it stays in the body at increased levels, the statement said.
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, the FDA said.
''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,'' the statement said.
It was the first HIV drug to be approved since an FDA advisory committee recommended more stringent reporting of clinical studies, under which all patients who start a trial, even those who drop out, are included in the results.
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