FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C

Let me be the first to say thank you Vertex!!!

All right guys, the cure is on!

miked


CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C. The Committee recommended by a vote of 18-0 the approval of telaprevir for those who were not treated previously and those who were treated previously but not cured with currently available medicines. Telaprevir was studied in all major subgroups of people who were treated previously and not cured: relapsers, partial responders and null responders. The FDA is expected to make a decision on the approval of telaprevir by May 23, 2011 , under the Prescription Drug User Fee Act (PDUFA). The FDA is not bound by the Committee's recommendation, but usually follows its advice.

In Phase 3 studies, telaprevir was given for 12 weeks in combination with pegylated-interferon and ribavirin (P/R) followed by P/R alone for a total of 24 weeks or 48 weeks of treatment. Data from these studies that were reviewed by the Committee showed that people who received telaprevir-based combination therapy achieved significantly higher rates of sustained viral response (SVR, or viral cure) compared to treatment with 48 weeks of P/R alone, regardless of their experience with prior treatment. Among people who were not treated previously, 79 percent achieved a viral cure with telaprevir-based combination therapy compared to 46 percent who achieved a viral cure with P/R alone.

Approximately two-thirds of people in Phase 3 studies who were not treated previously and who received telaprevir-based combination therapy were eligible to complete their treatment in six months — half the time needed with currently available medicines. Today, the FDA Committee discussed Vertex's request for the approval of response-guided therapy to allow for a six-month treatment duration for people who were not treated previously as well as for those who relapsed after prior treatment with P/R alone (prior relapsers). Side effects observed with telaprevir-based combination therapy were consistent across the Phase 3 studies. Rash and anemia occurred more frequently among those treated with telaprevir-based combination therapy compared with those who received pegylated-interferon and ribavirin alone.

"Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the Committee's unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C," said Peter Mueller , Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA as it prepares to make its decision next month."

[miked]

For those who don't know me.

I was a genotype 1b.  Went through my first tx on SOC in 2004.  Viral load went from 3M to 9,600 and about week 36 rose to 15,000.  Viral breakthrough, game over.

Over the following year I studied my options and decided that VX950 (Telaprevir) was my best option.  Was enrolled in the Vertex Prove 3 clinical trial and lucked out to be in the trial arm for 12 weeks of Telaprevir + INF + RBV followed by 12 weeks of INF + RBV.  

After the trial Vertex released that I became negative somewhere between week 1 and 2.  It's been over three years now and I am obviously HCV negative and totally have my life back!  

I'm so happy to have been at the computer 1 minute ago and seen this news come in real-time!!

This is such great news that the hard to treat geno 1b's will cut tx in half and more than double their chances for SVR with these new drugs.

TX ***** for sure but now the odds are in everyone's favor.

Holy shix!!  I'm just so happy to have been part of this and wish everyone the best.

miked

[Diane12855]

Such great news!!!

Now we just have to get the doctors educated about the need to screen everyone for HCV instead of waiting for elevated liver enzymes. Maybe some day we'll beat this **** virus once and for all.

Diane

[frijole]

It was exciting in real time, wasn't it.  You are a Vertex ambassador, aren't you?  Not sure what all that entails, but I think you are going to be very busy.
frijole

[miked]

Yes I am.  I can't comment too much until the drug is officially approved.

It's just such an exciting time right now to see FDA recommendations for Telaprevir and Boceprevir in the same day.  

People like Susan400 who trialed with VX950 but without RBV will now have an option. I'm sure there are people that Boceprevir didn't work out for them and Telaprevir is now an option.  

When I was diagnosed in 2004 my odds were pretty crappy as a geno 1b on SOC....something like 35%.  People being diagnosed today should be very optimistic.

miked