Medivir announced that its investigational drug TMC435 has received fast track designation by the FDA for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435’s potential to address unmet medical needs in the treatment of CHC infection compared to currently approved therapies. TMC435 may offer high sustained virological response rates in genotype-1 HCV-infected patients, including hard-to-treat subgroups, short treatment duration, favourable overall safety and tolerability profile, and a once-daily dosing regimen.
TMC435 is a CHC protease inhibitor currently in Phase 3 clinical trials being jointly developed by Tibotec and Medivir.
For more information visit www.medivir.com.