BMS files for FDA approval of protease inhibitor Zrivada

By Advocate.com Editors

Originally published on Advocate.com January 03 2003 1:00 AM ET

Pharmaceutical company Bristol-Myers Squibb this week applied for Food and Drug Administration approval of its experimental second-generation protease inhibitor Zrivada (atazanavir). The FDA application included data from Phase III clinical trials showing that the once-a-day drug is as effective as other protease inhibitors and does not cause blood lipid levels to rise, a problem common with existing protease drugs. More than 2,400 people have participated in studies of Zrivada, which is currently available through an early-access program for patients who have failed other anti-HIV medications. A decision by the FDA is expected by early summer.