Tibotec Pharmaceuticals announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naïve HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.
The regulatory application is based on the 48-week results of two pivotal phase-3 double-blind, randomized studies, known as ECHO (TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215), which evaluated the efficacy, safety and tolerability of once-daily TMC278 in treatment-naïve HIV-1-infected adults.
ECHO (Efficacy Comparison in treatment-naïve HIV-infected subjects Of TMC278 and EFV) evaluated TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV) (600 mg) once daily, combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate. THRIVE (TMC278 against HIV, in a once daily RegImen Versus Efavirenz) evaluated TMC278 (25 mg) once daily versus EFV (600 mg) 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). The studies were conducted at more than 100 sites in more than 20 countries, and enrolled 1,368 patients.
"The U.S. regulatory submission for TMC278 is an important step forward as Tibotec broadens its HIV treatment portfolio," said Eric Lefebvre, the director of Global Medical Affairs at Tibotec. "It is our goal to help as many patients as possible receive the treatment and care that they need. Upon approval, TMC278 may provide a new option for many patients starting treatment for the first time."
Pending FDA approval, Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, LP, will commercialize TMC278 in the United States. Regulatory submissions for TMC278 in other countries are expected in coming months. Tibotec has also entered into a license and collaboration agreement with Gilead Sciences, Inc for the development and commercialization of a once-daily fixed-dose combination of TMC278 and Gilead's Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Tibotec Pharma is a pharmaceutical research and development company. The company's main research and development facilities are in Beerse, Belgium, with offices in Titusville, New Jersey, USA.