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BRIEF-Gilead submits NDA for fixed-dose combination for HIV treatment
June 12, 2017 / 2:19 PM / 2 months ago

BRIEF-Gilead submits NDA for fixed-dose combination for HIV treatment

June 12 (Reuters) - Gilead Sciences Inc:

* Gilead submits new drug application to U.S. Food and drug administration for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for HIV treatment

* Investigational single tablet regimen may have potential to advance triple-therapy hiv treatment for a broad range of patients

* Plans to submit a marketing authorization application for bic/ftc/taf in european union in Q3 of 2017

* NDA for bic/ftc/taf is supported by data from four phase 3 studies in which regimen met its primary objective of non-inferiority Source text for Eikon: Further company coverage:

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