Therapy Areas: AIDS & HIV
Gilead Garners Positive Opinion from European Regulatory Agency for Biktarvy for Treatment of HIV-1
1 May 2018 - - The European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Foster City, California-based global research-based biopharmaceutical company Gilead Sciences, Inc.'s (NASDAQ: GILD) marketing authorization application (MMA) for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), the company said.
BIC/FTC/TAF is a once-daily single tablet regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine, or tenofovir.
BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor backbone.
The MAA for BIC/FTC/TAF is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks in all four studies.
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein. A European Commission decision is expected in mid-2018.
BIC/FTC/TAF was approved by the US Food and Drug Administration on February 7, 2018.
In the European Union, BIC/FTC/TAF is an investigational product and its efficacy and safety have not yet been established.
Gilead Sciences discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 40 countries worldwide.
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