Gilead (GILD) Application for HIV Drug Validated in EU

Gilead Sciences, Inc. GILD announced that the company’s Marketing Authorization Application (MAA) for a once-daily single tablet regimen containing bictegravir (50 mg; BIC) and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for the treatment of HIV-1 infection in adults has been fully validated by the European Medicines Agency (EMA). Currently, the application is under review by the EMA.

The regimen is novel experimental integrase strand transfer inhibitor which is being evaluated for the treatment of HIV-1 infection in adults.

Shares of Gilead have underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last year, with the stock losing 1.5% during this period, against the industry’s gain of 8.6%.

The MAA for BIC/FTC/TAF is based on data from four phase III studies in which the regimen met its primary objective of non-inferiority at 48 weeks. Out of these, three ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing GlaxoSmithKline’s GSK Tivicay (dolutegravir) (50mg) (DTG) among treatment-naïve patients and virologically suppressed patients switching from an existing antiretroviral regimen. The data from these studies showed that BIC/FTC/TAF demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks.

The fourth study is being conducted among virologically suppressed patients and compares switching to BIC/FTC/TAF versus on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Additionally, Gilead submitted a new drug application (NDA) for BIC/FTC/TAF in the U.S. on Jun 12, 2017. The company will present the48-week data from two phase III studies evaluating BIC/FTC/TAF compared to regimens containing Tivicay (50mg) (DTG) in treatment-naïve adult patients at the International AIDS Society Conference on HIV Science (IAS 2017),July 23-26, 2017, in…

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