Pharmasset's PSI - 938 fast tracked

PSI-938 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
Last update: 8/24/2011 6:45:00 AM
PRINCETON, N.J., Aug. 24, 2011 /PRNewswire via COMTEX/ -- Pharmasset, Inc. (VRUS) has received fast track designation from the U.S. Food and Drug Administration (FDA) for PSI-938 for the treatment of chronic hepatitis C virus (HCV) infection. PSI-938 is an oral guanosine nucleotide analog polymerase inhibitor of HCV.
In March 2011, Pharmasset presented data from the NUCLEAR study demonstrating that PSI-938 has potent antiviral activity and is generally safe and well tolerated, both as monotherapy and in combination with Pharmasset's lead nucleotide analog, PSI-7977. The NUCLEAR study was conducted in treatment naive subjects with genotype 1 HCV who were treated for 14 days with either PSI-938 or a combination of PSI-938 and PSI-7977 with 92% achieving HCV RNA <15IU/mL, the limit of detection, in the combination arms. Pharmasset plans to initiate QUANTUM, an interferon-free combination trial with PSI-938 and PSI-7977 in the third quarter of 2011.
Under the FDA Modernization Act of 1997, fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. PSI-938 was granted the fast track designation primarily due to the need for HCV treatments with improved tolerability, safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.

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[willbb]

Thx. for posting  Mike....these poly"s seem like the real deal
Will

[nygirl7]

Already making tela and boce out of date imagine that and here we waited how many years for them to be approved? Jez so much for us old SOCers LOL.

[scratchinghead]

Man, and I was just going to phone the specialist about starting treatment on the 3 combo that has been working. Guess I should wait a little longer. Thank you very much.

[OC]

i hear you...i'm supposed to start triple therapy soon...

[copyman]

For those that are thinking about waiting, keep in mind that "fast track" is not that fast. It means at least 2 years and as long as 5 years for FDA approval.
Each person along with their doctor has to make a decision when to treat. If liver damage is minimal then waiting is an option, if not then treat with the triple therapy now while you still can.

[Trish77]

Good info, Mike.

Now if PSI-7977 also gets fast-tracked, things will get even more interesting, with TMC435 having been fast-tracked as well.  It could be hyprbole but the company expects it to be on the market in 2012.

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

Some info from that article on what it means to be fast-tracked.

About Fast Track

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and to fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. "Filling an unmet medical need" is defined as providing a therapy where none exists or providing a therapy that may potentially be superior to existing therapy. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

-- Showing superior effectiveness

-- Avoiding serious side effects of an available treatment

-- Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome

-- Decreasing a clinically significant toxicity of an accepted treatment

A drug that receives Fast Track designation is eligible for some or all of the following:

-- More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

-- More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials

-- Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate or substitute endpoint reasonably likely to predict clinical benefit

-- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA

-- Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

[Flowerchild700]

Do you know if it will help those of us that already advanced cirhosis?

[mikesimon]

I haven't seen any studies of cirrhotics treated with Pharmasset's drug so I don't know for sure.
Histology has always been a factor in treatment of HCV and it will probably continue to have an impact with these newer drugs as well. But, I also suspect that these new therapies will  increase the odds of success in cirrhotic patients as well in patients with better histology.

Mike

[vdubs53]

http://www.prnewswire.com/news-releases/psi-7977-receives-fast-track-designation-from-the-fda-for-the-treatment-of-chronic-hepatitis-c-infection-100518109.html

[orphanedhawk]

I guess it'd be ridiculous to for some one post transplant to think that this would be an option any time in the near future.
I'd participate in a clinical trial in a heartbeat.

[OC]

If you fail with triple therapy (incivek), does that preclude you from doing this "all oral" treatment?

peace

[copyman]

I remember both of the new drugs were fast tracked when I first found out I had Hep C. That was back in 2006. I waited for a long time before I finally got into a trial with Telaprevir. They both were approved earlier this year. You can do the math.

All I'm saying is if you have a chance get rid of the disease as fast as you can. Treat with the new drugs. This disease does more damage to people then just their livers. The extra hepatic manifestations are greater then you can ever imagine.