Regulatory Decision Summary for Symtuza
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Type of submission:
What was the purpose of this submission?
The purpose of this New Drug Submission for market authorization of Symtuza (a fixed dose combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide), which is indicated for the treatment of human immunodeficiency type 1- infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg) who have no known mutations associated with resistance to the individual components of Symtuza.
Why was the decision issued?
Health Canada considers that the benefit/risk profile of Symtuza is favourable when used as directed in the treatment HIV-1 infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg) who have no known mutations associated with resistance to the individual components of Symtuza.
Symtuza is formulated as a fixed dose combination tablet containing 800 mg darunavir ethanolate, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
The clinical safety and efficacy of Symtuza is based on safety and efficacy data from clinical trials conducted with Prezcobix and Genvoya as well as a Phase 2 trial submitted in support of the current application, which compared the safety and efficacy of Symtuza to Prezcobix plus Descovy. The benefits of Symtuza include more favourable bone and renal safety profiles as compared to combinations containing tenofovir disoproxil fumarate and a higher genetic barrier to resistance with the addition of darunavir.
The harms associated with Symtuza are consistent with those associated with other antiretroviral combination regimen such as post-treatment exacerbation of hepatitis, immune reconstitution inflammatory syndrome, pancreatitis and drug-drug interactions.
The uncertainties associated with the use of Symtuza are long-term effects on bone mineral density and the long term clinical significance of increased serum lipids.
The harms and uncertainties associated with the use of Symtuza are manageable through the inclusion of appropriate contraindications, warnings and cautionary statements in the Symtuza Product Monograph.
The overall benefit-harm-uncertainty profile of Symtuza supports the approval of this fixed dose combination for the treatment of HIV-1 infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg) who have no known mutations associated with resistance to the individual components of Symtuza.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.