FDA Confirms Paragraph IV Patent Litigation for Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
FDA Confirms Paragraph IV Patent Litigation for Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today presented three-year results from the TANGO study at IDWeek 2021, being held virtually 29 September - 3 October. Findings showed that the 2-drug regimen (2DR) Dovato (dolutegravir/lamivudine) continued to demonstrate non-inferior efficacy and a high barrier to resistance compared to continuation of tenofovir alafenamide fumarate (TAF)-based regimens of at least three drugs in virologically suppressed adults living with HIV-1 who had not experienced prior virologic failure. At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3/372]) on the TAF-based regimen. No resistance mutations were reported in either arm.
FDA Confirms Paragraph IV Patent Challenge of Vemlidy 208464 (Tenofovir Alafenamide Fumarate) Tablets
FDA Confirms Paragraph IV Patent Challenge of Descovy 208215 (Emtricitabine and Tenofovir Alafenamide Fumarate) Tablets
FDA Confirms Paragraph IV Patent Challenge of Odefsey 208351 (Emtricitabine, Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate )Tablets
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