The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for HIV-1 drug candidate Biktarvy.
Biktarvy is a combination of 50mg bictegravir, 200mg emtricitabine and 25mg tenofovir alafenamide (BIC/FTC/TAF).
Bictegravir is an integrase strand transfer inhibitor, and the combination of emtricitabine and tenofovir alafenamide is a dual nucleoside reverse transcriptase inhibitor.
In the MAA, the company is seeking approval for Biktarvy as a once-daily single tablet regimen for adults who do not have any present or past evidence of viral resistance to emtricitabine or tenofovir alafenamide.
The MAA includes results from four separate ongoing Phase III clinical trials, two involving treatment-naïve patients, and two involving virologically suppressed subjects. A total of 2,415 adult participated in the trials.
The trials are reported to have met the primary objective of non-inferiority at 48 weeks.
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Gilead Sciences chief medical officer Andrew Cheng said: “Triple therapy has been the standard of HIV treatment for more than 20 years and has allowed people living with HIV to achieve durable undetectability.
“At Gilead, we have continued to explore ways to improve and provide more HIV treatment options, with the goal of going beyond reducing viral load and helping to address some of the wider challenges faced by people living with HIV.”
Cheng added that if approved, Biktarvy will be the fifth TAF-based product for HIV approved in the EU in the last three years.
The drug interaction profile, minimal monitoring requirements and ease of administration represent a meaningful advance in HIV treatment in Europe.