Second generation triple therapy.

[willbb]

From a post in June 2012

I have followd the data on this particular drug since it's inception and I feel it may be the next 'Protease" to hit the market ..before the all orals

Same type drug as Vic  & Inci (taken with INF. /Riba) ,however data shows in PH 2 trial to be effective with 1) "Only once a day dosing"  2 )NO fat requiements and 3)Very few side effects.


Noticed today:. ( Simeprevir) Ph. 3 Quest trials show much promise for naive and experinced patients

. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C

13-May-13 Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.

“This is a very important step bringing simeprevir closer to the market, making this therapy available to hepatitis C patients” comments Charlotte Edenius, EVP Development of Medivir.

The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.

The regulatory submission by Janssen for simeprevir is supported in part by data from three pivotal phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. Janssen also recently submitted simeprevir for marketing authorization to regulatory authorities in Japan and Europe.

http://www.medivir.se/v4/en/ir_media/pressrelease.cfm?year=2013&releaseid=772070



My apologies if this has been posted about recently..Not here as much as I used to be..

Will

[Dee1956]

Hy Will, great to see you! Hope you are doing well, thanks so much for this information.  It is really interesting to hear of another drug under research.
Thanks
Dee

[1swimmer]

I thought  this post was quite interesting. A PI once a day would be much easier than the 8-8-8 time schedule many of us endured. And fewer sx... I plan on reading up some more. Thanx for the info.
C
also, thanx for note, and hope all is well with you.