-- Company to Submit U.S. Regulatory Filing for Elvitegravir in Second Quarter of 2012 --
Gilead Sciences, Inc. GILD +0.85% today announced topline Phase 3 clinical trial results showing that elvitegravir, an integrase inhibitor being evaluated for the treatment of HIV-1 infection, was non-inferior to the integrase inhibitor raltegravir after two years (96 weeks) of therapy in treatment-experienced patients. Gilead plans to file for U.S. regulatory approval of elvitegravir in the second quarter of 2012.
"These positive two-year data indicate that elvitegravir has the potential to be an important new once-daily treatment option for people living with HIV who have developed resistance to other therapies," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "In addition, we are very excited about elvitegravir's role as part of our new Quad single-tablet regimen, which is currently in U.S. regulatory review."
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