FW: NATAP: Schering HCV Protease Inhibitor-FDA Fast Tracks
- Schering-Plough HCV Protease Inhibitor: FDA Grants Fast Track
Schering Plough released this press announcement today.
SCHERING-PLOUGH REPORTS FDA GRANTS FAST TRACK DESIGNATION TO ORAL HCV
PROTEASE INHIBITOR SCH 503034
KENILWORTH, N.J., Jan. 30, 2006 - Schering-Plough today reported that the
U.S. Food and Drug Administration (FDA) has granted Fast Track designation
to its investigational oral hepatitis C protease inhibitor (SCH 503034),
currently in Phase II clinical development for the treatment of chronic
hepatitis C virus (HCV) infection.
The FDA granted Fast Track designation for the following reasons:
o The proposed first indication for SCH 503034 is for treatment of HCV
in patients with HCV genotype 1 virus who have not responded to combination
therapy with pegylated interferon and ribavirin, the current standard of
care, thus representing an unmet medical need.
o SCH 503034 is an orally active inhibitor of the hepatitis C virus
serine protease that inhibits HCV replication. This mechanism is distinct
from those of current therapies, thus SCH 503034 represents a novel class of
Fast Track designation allows FDA to expedite review of drugs and biologics
for serious or life-threatening conditions and which demonstrate the
potential to address unmet medical needs. An important feature of Fast
Track designation is that it emphasizes the critical nature of close, early
communication between the FDA and the sponsor company to improve the
efficiency of product development.
Here are links to first report of study data in patients reported at AASLD
SCH 503034 HCV Protease Inhibitor Monotherapy in HCV Genotype 1 IFN
Combination therapy with SCH-503034 HCV Protease Inhibitor & PegIntron in
Non-Responders: phase !b study results (11/15/05
NATAP nataphcv mailing list -- nataphcv@...
This is an annoucement-only mailing list. Do not reply.
To unsubscribe: send a blank email to nataphcv-request@... with a subject of unsubscribe.
For more information, see http://seven.pairlist.net/mailman/listinfo/nataphcv
[Non-text portions of this message have been removed]