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Gilead Files Once-Daily Integrase Inhibitor Elvitegravir With FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Part of the Quad combination product, stand-alone elvitegravir could open up the integrase inhibitor market. In a study supporting the single-agent NDA, once-daily elvitegravir proved comparable to Merck’s twice-daily blockbuster Isentress, the only commercially available integrase inhibitor.

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