Norvir Launch Soon As FDA Clears 2nd Protease Inhibitor

The US Food and Drug Administration has approved a second HIV protease inhibitor, Abbott Laboratories' Norvir (ritonavir), within hours of its backing by the FDA's Antiviral Drugs Advisory Committee on March 1. Merck & Co's Crixivan (indinavir) was also recommended for approval at the ADAC meeting.

A spokesman for Abbott said that Norvir would be shipped in "a couple of weeks." The new protease inhibitor joins Hoffmann-La Roche's Invirase (saquinavir), which was launched in the USA in December 1995, and sets a new record for review times at the FDA at just 72 days.

Merck said that it thought that Crixivan's approval was imminent and that the product should be launched in the USA on April 1. The ADAC recommended accelerated approval for Merck's Crixivan on the basis of surrogate marker data, viral load and CD4 counts, seen with the drug when it was used either alone or in combination with existing treatments.