FDA Grants Fast Track to HCV Protease Inhibitor SCH 503034
Another one hits the “track”.
Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034
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:
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.
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 HCV inhibitor.
Status of SCH 503034 Clinical Development
SCH 503034 has demonstrated potent antiviral activity and was well- tolerated, both as monotherapy(1) and in combination with PEG-INTRON(R) (peginterferon alfa-2b),(2) in Phase I clinical studies in patients chronically infected with HCV genotype 1 who were nonresponders to previous therapy, including peginterferon and ribavirin combination therapy. Results of Phase I clinical studies with SCH 503034, including in healthy subjects,(3) were presented at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2005. HCV genotype 1 is the most common form of the virus worldwide and is considered the most difficult to treat successfully.
April 5th, 2006 at 6:05 am
Please send any updated materials to me. I am Hep c and is being treated. I have the genotype not very responsive to treatment. I am willing to try any new medication.
June 10th, 2006 at 10:44 am
My coment is related to that said that is like this Many times is not about what you have…..But what We Can Pay, How Much money we have to ofer to get The best medication or to get The best treatment That is outthere.I Knew or had a friend that he neded a liver for his body and he gotit but like five months to a year his body regected and he put himself on the list to wait. But because of the money that him and his family can ofer he did not had to wait that long to bget another transplant. and also the second liver that he got the body doesnot wanted to work with. Today hes allready with God.We can have any virus and it doesnot mean that we goig to die fromit May our Powefull God Bless you,Me, and every human bin (friend)
October 10th, 2006 at 4:41 pm
I need information on Grants for medication Pegasyst/copasyst I have HCV Geno type 2b
May 28th, 2007 at 8:42 am
Just started a trail with the SCH. 12 a day in combo with peg intron & ribavirin
started the sch 4 weeks after the peg& riba. My First peg inj. gave me the chills bad about 6 hours later. Staying hydrated seems to work I have symptoms the following day but not so that I can’t Function I just don’t want
to I have found through my own clinical trail that juicing up 3 oranges and
a giant plate of spaghetti and a fair amount of water not to over do it on the water. I have tried this combo once by chance and thought I took a placebo
the next day no symptoms tried it again the following week same result, next
week a lot of water didn’t eat anything extra, felt bad all day the next day.
this week I went back to the OJ and spaghetti trick and wham life continues on just like nothing ever happened. Just a little hyper doing yard work
with a cat nap during the day. anyway i hope some one else will see this and either join my trail to be symptom free.
June 23rd, 2007 at 7:26 am
I AM DRUG RESISTANT. I HAVE BEEN ON 3 TRIALS. EACH ONE WITH INTERFERON AND RIB. THE LAST ONE LASTED 7 MONTHS AND INCLUDED SCH. I GOT THE STRONGEST DOSAGE AND ALTHOUGH MY LOGS DID GO DOWN EVENTUALLY MY VIRUS MUTATED AND REPRODUCED ITSELF.
ALONG WITH ALL OF THE LISTED SIDE EFFECTS I ALSO HAD TO BE ON NUPREGON AND PREMIGEN BECAUSE MY BLOOD DID NOT REACT WELL TO THE MEDS. I NOW HAVE FOUND OUT THAT MY TEETH WERE ALSO EFFECTED NEGATIVELY TO THE MEDICINE. HAS ANYONE ELSE HAD THIS SIDE EFFECT?