Regulatory Decision Summary for Evotaz
Review decision
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.
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What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain marketing authorisation for Evotaz, a new antiretroviral product for the treatment of HIV-1 infection in combination with other antiretroviral agents. Evotaz is a co-formulation of the protease inhibitor atazanavir with the pharmacokinetic booster cobicistat in a single tablet.
Why was the decision issued?
Currently the individual active ingredients of Evotaz, atazanavir, and cobicistat, are available on the market as separate products and are used together as components of antiretroviral regimens. Atazanavir is a protease inhibitor and cobicistat is a new pharmacokinetic booster that is a selective inhibitor of cytochromeP450 (CYP) 3A, the main metabolizing pathway of several antiretrovirals. Cobicistat provides another option to the medical provider from the perspective of an alternative drug-drug interaction profile as compared to the one obtained when boosting atazanavir with ritonavir in the context of usage of concomitant medications.
The benefits of the use of atazanavir and cobicistat in combination have already been demonstrated in previous regulatory submissions. In general, the presence of a protease inhibitor in an antiretroviral regimen always offers a high barrier to resistance. Having a new single-tablet option for a boosted protease inhibitor reduces pill burden and it will likely improve patient adherence to treatment. Therefore, Evotaz is a fixed-dose, single-tablet, combination product that will help achieve a sustained viral suppression and minimize the risk of treatment failure.
The safety and efficacy of Evotaz was demonstrated in a pivotal comparative bioavailablity study. Overall, the safety profile of Evotaz was similar to the known profile and safety data reported for the two individual components, atazanavir and cobicistat. Evotaz was generally safe and well tolerated.
In conclusion, the anticipated benefits of Evotaz are considered to outweigh the potential risks from this new fixed-dose combination.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.