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news.Tibotec Pharmaceuticals has submitted a new drug application (NDA) to the FDA for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.
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Tibotec Pharma said that, TMC278 will be the third anti-HIV compound to be introduced by the company, if approved by FDA.
Tibotec Pharma has applied for the approval based on the results of two pivotal Phase 3 double-blind, randomised studies, known as ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV (TMC278-TiDP6-C209)) and THRIVE (TMC278 against HIV, in a once daily RegImen versus Efavirenz (TMC278-TiDP6-C215)), which assessed the efficacy, safety and tolerability of once-daily TMC278 in treatment-naive HIV-1-infected adults.
ECHO evaluated TMC278 (25mg) once daily oral tablet versus efavirenz (EFV) (600mg) once daily, combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate.
THRIVE evaluated TMC278 (25mg) once daily versus EFV (600mg) once daily, combined with an investigator-selected background regimen consisting of two N[t]RTIs (abacavir + lamivudine or emtricitabine + tenofovir disoproxil fumarate or zidovudine + lamivudine).
Pending FDA approval, TMC278 is expected to be commercialised in the US by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products. Regulatory submissions for TMC278 in other countries are expected in coming months.
Additionally, Tibotec Pharma has also entered into a license and collaboration agreement with Gilead Sciences for the development and commercialisation of a once-daily fixed-dose combination of TMC278 and Gilead’s Truvada(emtricitabine 200mg/tenofovir disoproxil fumarate 300mg).
Eric Lefebvre, director of global medical affairs at Tibotec Pharma: “The US regulatory submission for TMC278 is an important step forward as Tibotec Pharma broadens its HIV treatment portfolio.”