Posted by Michael Wonder on 13 Apr 2020
Gilead Canada submits supplemental new drug submission to Health Canada for Descovy for HIV pre-exposure prophylaxis
9 April 2020 - Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy compared to Truvada in people at risk for sexually acquired HIV-1 infection.
Gilead Sciences Canada announced today that the company has submitted a supplemental new drug submission to Health Canada for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Descovy is being evaluated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.
The submission is based on data from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in reducing the risk of acquiring HIV-1 infection.
