GLAXO WELLCOME EPIVIR RECOMMENDED FOR ACCELERATED APPROVAL BY ANTIVIRALS COMMITTEE; UNCERTAINTY EXPRESSED OVER FIRST-LINE AND PEDIATRIC USE
Executive Summary
Glaxo Wellcome's Epivir (3TC, lamivudine) merits accelerated approval based upon available efficacy data, FDA's Antiviral Drugs Advisory Committee concluded Nov. 6. The committee voted 7-0 with one abstention in favor of accelerated approval of the 3TC/Retrovir (zidovudine, AZT) nucleoside combination in treatment-experienced adults within the CD4 cell counts studied in previous trials.