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FDAnews Drug Daily Bulletin

Biktarvy Earns Chinese Approval for Treating HIV

Aug. 15, 2019

China’s National Medical Products Administration has approved Gilead’s Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) for treatment of HIV-1 infections in adults.

The drug’s approval is supported by data from four ongoing phase 3 studies that showed the drug met its primary efficacy goal of non-inferiority at 48 weeks. Throughout the year, no participants developed resistance while taking the medication, and none stopped use of the drug due to renal, bone or hepatic adverse events.

The drugmaker said that China saw approximately 150,000 newly diagnosed cases of HIV in 2018. The government has provided free antiretroviral treatments to patients with the virus since 2003.

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