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AMBER Data Support Green Light For Janssen's Symtuza

 
• By Alexandra Shimmings

More Phase III data for Janssen's first once-daily single tablet containing four drugs for use against HIV Symtuza support its use in treatment-naïve patients; the product awaits US approval.

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Amber light precedes go for Symtuza • Source: Shutterstock

Janssen Inc.'s single-tablet regimen for HIV, Symtuza, is as effective as its component drugs taken in multiple pills in previously untreated patients infected with HIV-1, data from the AMBER study show. The data form part of Janssen's NDA filing for the product made to the US FDA in September.

Symtuza contains darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF) in one once-daily tablet and was compared with darunavir/cobicistat (D/C) plus emtricitabine and...

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