Roche Submits New Invirase Application to FDA

Roche Holding AG has submitted an application to the US Food and Drug Administration for a new formulation of its HIV drug saquinavir (Invirase), the Swiss drugmaker said on Monday.

The new formulation is smaller in size than the capsule that is currently available and, if approved, will reduce daily pill count for each dose from five pills to two, twice daily, the company said in a statement.

Roche said it would file for European Union approval to market the new formulation within days of the U.S. filing.

In December, the U.S. Food and Drug Administration approved 1000 milligrams of the protease inhibitor for use in combination with Norvir (ritonavir), a drug made by Abbott Laboratories Inc., and other anti-HIV drugs, Roche said.

"Today's filing is based on a .... study demonstrating that two 500 milligrams tablets of Invirase, together with 100 milligrams of ritonavir, achieve similar levels of Invirase in the blood as five Invirase 200 milligrams with 100 milligrams of ritonavir," Roche said in a statement.

Roche shares closed on Monday at 129.75 francs.

06/23/04



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