TMC435 granted fast track status by FDA

http://www.hepatitis-central.com/mt/archives/2011/07/hepatitis_c_dru_3.html?eml=hepcen138

Boasting several benefits over the currently approved Hepatitis C drugs, Medivir's TMC435 has been granted fast track status by the FDA. Additionally, TMC435 will partake in a new trial to assess its validity within an interferon-free regimen.

Medivir: TMC435 has Received Fast Track Designation from the FDA and TMC435 will be studied in combination with Pharmasset's PSI-7977 for HCV genotype-1

HUDDINGE, Sweden, Jul 06, 2011 (BUSINESS WIRE) -- Regulatory News:

Medivir AB (sto:MVIRB)(omx:MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases.

Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435's potential to address unmet medical needs in the treatment of 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

-- Short treatment duration

-- Favorable overall safety and tolerability profile

-- A convenient once-daily (q.d.) dosing regimen

Continue reading this entire article:
http://www.marketwatch.com/story/medivir-tmc435-has-received-fast-track-designation-from-the-fda-and-tmc435-will-be-studied-in-combination-with-pharmassets-psi-7977-for-hcv-genotype-1-2011-07-06?reflink=MW_news_stmp

[CaughtOffGuard]

This is very good news!  Sign me up!

[sandysf]

does this mean it could be approved in 6 months?  

[andy_k]

i believe TMC435 is still in clinical trials, so it is at least a couple of years away.

in this case fast track allows drug researchers to communicates faster with FDA.
IMHO

[coeric]

this is a second generation PI. looks like about the same efficacy as telaprivir but with fewer side effects and once a day dosing.  was offered the stage 3 clinical trial but turned it down.  placebo group was 1/3 of total and no roll over.  the study nurse said i had to hurry and make up my mind because it was closing this month.  data collection will take 18 months.  analysis and submission time to FDA will take perhaps 12 months so my guess is 2 to 3 years.

[Trish77]

http://www.bloomberg.com/news/2011-07-13/j-j-has-to-resolve-hepatitis-c-drug-conflict-medivir-ceo-says.html?cmpid=yhoo

"Medivir is developing its TMC435 tablet with New Brunswick, New Jersey-based J&J’s Tibotec Pharmaceuticals Ltd. unit. The Huddinge, Sweden-based biotechnology company said last week the experimental treatment will get a faster review from the U.S. Food and Drug Administration. The medicine may go on sale in late 2013, Medivir CEO Ron Long said in an interview yesterday in London."

[curiouslady1]

I will be enrolling in an all pill study with 7977 and BMS 790052 and with an arm that gets Riba too. The study is 6 months.  My research doc told me that they don't do "control" groups anymore with HepC.  I am not sure if he meant his own program or in general.  I believe he means that everyone gets some medicine; some more than others and that is what it looks like if it is the study I think it is.  I think the chances of my clearing are good whether I get two drugs or three.  One cannot change one's arm but must go to SOC if failed.  They are still recruiting for this study I think.  Treatment naivete is required.  I don't know about cirrhosis but it doesn't appear to be an exclusion factor.  

[coeric]

Inquiring minds want to know how you fare with this treatment so please keep us informed. I had a discussion with my PCP about clinical trials and his advice was to be conservative - stick with drugs that have been shown to work.  if i were stage 2 or less i would consider an interferon sparing trial.  but with advanced fibrosis this would be a big gamble.
blessings
eric

[WriteItDown]

My husband was in the Phase IIb trial of TMC435 and is now SVR. This drug was good to us and he got through the tx with little or no sides that we didn't expect from SOC alone.

I am glad they fast-tracked this since it seems superior to both Tela and Boc -- similar or a bit better SVR rates, no rash or increased anemia, and once a day protocol.

Too bad they have such a large control arm in the Phase III study.... however, I would still advise anyone considering it to jump on, and jump off again if you discover early on you're getting the placebo.