Roche's Invirase Made Available In USA

Hoffmann-La Roche has announced that it will make its protease inhibitor Invirase (saquinavir) available to patients with HIV infection in the USA, without charge, via a lottery system. The company has drawn up an agreement with the US Food and Drug Administration stipulating a suitable protocol for distributing enough drug to treat 2,280 patients who are not eligible for entry into trials. Another lottery may be set up if more drug becomes available.

This is the first time that a protease inhibitor has been made available to patients on compassionate-use grounds, outside the confines of a clinical trial. The lottery will be managed by Parexel, a clinical research organization. Since the publication of positive data a few months ago on the ability of these agents to reduce viral load in patients, Roche, as well as other developers of protease inhibitors and the FDA, have been lobbyed by AIDS activists seeking to get access to the medications.

Roche says it plans to file a New Drug Application for Invirase under the fast-track mechanism in September of this year, on the basis of interim data from a Phase III trial of the drug in North America, along with data from earlier studies. The results of these trials are reported to show the tolerability and activity of Invirase as a monotherapy and in combination with Glaxo Wellcome's Retrovir (zidovudine).