Foster City-based Gilead Sciences, a manufacturer of commercial therapies for viral diseases, infectious diseases and cancer, is willing to acknowledge the FDA’s recommendation of doubling the length of its late-stage study of HIV drug candidate elvitegravir to roughly two years.
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The study compares elvitegravir to Merck & Co’s drug Isentress, and will now last 96 weeks instead of 48 weeks, reported Bloomberg.com.
Gilead said the extension will allow it to collect longer-term safety and effectiveness data in a filing with the Securities and Exchange Commission.
However, the extension will not affect trials of Gilead’s four-drug ‘quad’ cocktail – a combination of drug candidates elvitegravir and cobicstat along with its already-approved Truvada therapy – into a single tablet.
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