FDA
Grants "Fast Track" Development Status to New Oral Drug R7128 for Treatment of
Chronic Hepatitis C
The
U.S. Food and Drug Administration (FDA) has granted "fast track" designation
to R7128,
an oral HCV polymerase inhibitor in development by Pharmasset, Inc. in collaboration
with Roche Laboratories.
Fast track designation is given to experimental
drugs for the treatment of life-threatening illnesses (such and HIV
disease and chronic hepatitis C) that have
shown the potential to meet an unmet medical need. This status facilitates the
development and speeds the agency's review of such drugs.
FDA has granted
fast track status to R7128 due to the urgent need for new oral anti-HCV therapies
with novel mechanisms of action, different resistance profiles, and improved safety
and efficacy compared with currently available treatments for chronic hepatitis
C.
R7128
is a prodrug of PSI-6130, an oral cytidine nucleoside analog HCV polymerase inhibitor.
Pharmasset is currently enrolling participants in a 28-day Phase 1 clinical trial
to evaluate R7128 in combination with pegylated
interferon alfa-2a (Pegasys) plus ribavirin (Copegus) in treatment-naive patients
with chronic HCV genotype 1 infection.
"The FDA's fast track designation
for R7128 acknowledges the urgent need for new HCV drugs," stated Dr. Michelle
Berrey, Pharmasset's Vice President, Clinical Development and Chief Medical Officer.
"Currently, there are no HCV polymerase inhibitors approved for the treatment
of chronic HCV infection. We continue to work closely with our HCV partner, Roche,
and the FDA on the development and regulatory review of R7128, which has demonstrated
potent antiviral activity and has been generally well-tolerated in clinical trials
to date."
Source Pharmasset,
Inc. R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic
Hepatitis C Infection. Press Release. October 24, 2007.
