Regulatory Decision Summary for Odefsey
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?
The purpose of this New Drug Submission was to seek marketing authorization for Odefsey (emtricitabine, rilpivirine [as rilpivirine hydrochloride] and tenofovir alafenamide [as tenofovir alafenamide hemifumarate]), a complete, once-daily regimen, for the treatment of human immunodeficiency virus type 1 infection in adults who have no known mutations associated with resistance to the individual components of Odefsey and who have a viral load ≤ 100,000 copies/mL.
Why was the decision issued?
Health Canada considers that the benefit/risk profile of Odefsey is favourable when used as directed in the treatment of HIV-1 infection in adults.
Odefsey is formulated as a fixed dose combination tablet comprising 200 mg emtricitabine, 25 mg rilpivirine and 25 mg tenofovir alafenamide. The recommended dosing of this regimen is one tablet, once daily.
There were no Phase 2 or Phase 3 clinical safety and efficacy trials conducted specifically for Odefsey. The clinical safety and efficacy of Odefsey is based on previous safety and efficacy data from clinical trials conducted with Genvoya, Edurant, and Complera. The benefits of Odefsey are more favourable with respect to bone and renal safety profile as compared to combinations containing tenofovir disoproxil fumarate.
The harms associated with Odefsey are consistent with those associated with other antiretroviral combination regimens, such as lactic acidosis and severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis, immune reconstitution inflammatory syndrome, pancreatitis and drug-drug interactions.
The uncertainties associated with the use of Odefsey are long-term effects on bone mineral density and long-term clinical significance of increased serum lipids and lipodystrophy.
The harms and uncertainties associated with the use of Odefsey are manageable through the inclusion of appropriate contraindications, warnings and cautionary statements in the Odefsey Product Monograph. The overall benefit-harm-uncertainty profile is favorable for Odefsey in the treatment of HIV-1 infection in adults under the conditions of use as described in the Product Monograph.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ODEFSEY | 02461463 | GILEAD SCIENCES CANADA INC | EMTRICITABINE 200 MG RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) 25 MG TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) 25 MG |