The Center for Drug Evaluation (CDE) has indicated that Viatris Pharmaceuticals Co., Ltd’s efavirenz/lamivudine/tenofovir is set for prioritized review. The drug is used to treat HIV/AIDS, combining three active ingredients to target viral replication.
Drug Profile
- Efavirenz: A non-nucleoside reverse transcriptase inhibitor (NNRTI) that prevents HIV-1 transcription and replication.
- Lamivudine: A nucleoside reverse transcriptase inhibitor (NRTI) that blocks HIV reverse transcriptase and hepatitis B virus polymerase.
- Tenofovir: An acyclic nucleotide reverse transcriptase inhibitor (NRTI) with strong inhibitory effects on HIV and hepatitis B virus (HBV).
Global Approvals
The compound is marketed abroad under two single-dose regimes:
- Symfi Lo: Efavirenz 400mg, lamivudine 300mg, tenofovir disoproxil fumarate 300mg, approved for HIV-1 infected adults and children ≥35 kg.
- Symfi: Efavirenz 600mg, lamivudine 300mg, tenofovir disoproxil fumarate 300mg, approved for HIV-1 infected adults and children ≥40 kg.-Fineline Info & Tech
