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Home » Medivir receives Fast Track designation from FDA

Medivir receives Fast Track designation from FDA

July 6, 2011
CenterWatch Staff

Medivir’s investigational protease inhibitor TMC435 has received Fast Track designation from the FDA for treatment of chronic hepatitis C (CHC) genotype-1 infection, based on its potential to address medical needs in CHC infection compared to currently approved therapies.

TMC435 may offer high sustained virological response (SVR) rates in genotype-1 HCV-infected patients including hard-to-treat subgroups. It may also offer short treatment duration, an overall safety and tolerability profile and a convenient once-daily dosing regimen.

Medivir also will start a proof-of-concept oral, interferon-free phase II trial investigating the combination of TMC435, a once-daily NS3/4A protease inhibitor (PI), and Pharmasset's PSI-7977, a once-daily nucleotide NS5B polymerase inhibitor.

The study will investigate the efficacy and safety of 12 weeks or 24 weeks of TMC435 150 mg q.d. in combination with PSI-7977 400 mg q.d. with or without ribavirin in prior null responders to peginterferon/ribavirin therapy. The primary endpoint will be sustained virological response at 12 weeks (SVR12).

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