FDA gives fast track status to Medivir for CHC drug

In addition to that the company expects to begin a Phase 2 trial to evaluate combination of TMC435 and Pharmasset’s PSI-7977 for CHC treatment.

The primary endpoint of the trial will be sustained virological response at 12 weeks (SVR12).

Medivir CSO Bertil Samuelsson said they are delighted to have received the fast track designation for TMC435 from the FDA.

"This shows that TMC435, with its high safety profile, efficacy, short treatment duration and convenience of once daily dosing, is believed to have the potential to provide benefit over current treatments," Samuelsson said.