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Finally: Vertex Submits Application for Telepravir
Vertex submits application for hepatitis C drug
November 23, 2010 07:50 AM E-mail| |Comments (0)| Text size – + E-mail this article To: Invalid email address Add a personal message: Your e-mail: Invalid email address
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Vertex Pharmaceuticals Inc. said today that it has completed the submission of a New Drug Application that seeks regulatory approval for telaprevir, a hepatitis C drug candidate with the potential to generate billions of dollars in annual revenue.
The submission includes a request to the US Food and Drug Administration to reduce the FDA’s review time from 10 months to six months, Cambridge-based Vertex said in a press release.
The release included a statement Matthew Emmens, the company's chairman, president, and chief executive.
“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” Emmens said. “We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”
A recent Globe story noted that Vertex was on the verge of moving forward on telaprevir. One challenge: Global drug giant Merck & Co. is developing its own hepatits C drug candidate that could compete with telaprevir for the same market.
November 23, 2010 07:50 AM E-mail| |Comments (0)| Text size – + E-mail this article To: Invalid email address Add a personal message: Your e-mail: Invalid email address
Sending your articleYour article has been sent. Globe Staff
Vertex Pharmaceuticals Inc. said today that it has completed the submission of a New Drug Application that seeks regulatory approval for telaprevir, a hepatitis C drug candidate with the potential to generate billions of dollars in annual revenue.
The submission includes a request to the US Food and Drug Administration to reduce the FDA’s review time from 10 months to six months, Cambridge-based Vertex said in a press release.
The release included a statement Matthew Emmens, the company's chairman, president, and chief executive.
“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” Emmens said. “We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”
A recent Globe story noted that Vertex was on the verge of moving forward on telaprevir. One challenge: Global drug giant Merck & Co. is developing its own hepatits C drug candidate that could compete with telaprevir for the same market.
In about 1 month the FDA will either give Telaprevir fast track (6mo) evaluating drug for approval, or regular time for review is 1 year. If it is given fast track, we will know in January. Then count 6 months, sounds like July on the market, ready to go, if approved and I think it will be both fast tracked and approved. Late June or sometime in July 2011 is what I'm estimating.
The standard review process is 10 months long. Vertex has asked for a priority review and that will take 6 months if they are granted it.
Thanks for posting this article, i only wonder, if this means that Telaprevir, will be available spring 2011?
Interesting... I heard everything from 4 months, to 6, and now 11 months. I would imagine it's the mind set of the Gastro or Hepa who will make the final decision depending on our past failures? I'm with you as far as tolerance. I've been very fortunate to not have Anemia through 4 attempts, but the anger and rage at times did set in. That's what I have to watch. As far as working out with weights, I did throughout all treatment attempts, albeit it was difficult, but the Gastro suggested I keep it up. Very exhausting... as exhausting as waiting for the new PI's to come out...
Mag
Mag
I'm confused. Is this application some kind of million page document, or am I reading this wrong? Why do they submit a part of the application at a time instead of just getting the whole thing in at once?
Diane
Diane
Yes!
After reading this news today, I went to the FDA's site and looked up what exactly they mean by "Priority review". VX 950 (Telaprevir) has been on Fast Track for at least a year, and under this program FDA and the drug companies work more closely together than is normal to facilitate the submission process. The submitter can also request a priority review if the drug meets FDA's criterion. Vertex has done so, and it appears to me that they easily fit the requirements. FDA's site states that after a submitter asks for a priority review, FDA has 45 days to submit the new drug for review. Then the FDA has an upper limit of 6 months to either reject or approve the request for approval. One of the articles that I read today seemed to hint that this priority review will take the full 6 months, and it may, but it can also possibly be finished in less time. FDA's site used as an example "Pegasys" ( I guess we're all familiar with this one). Pegasys was granted a priority review, and it was approved in only 4 months! I'm hoping for the best, because after nearly 6 years of watching and waiting, I'm beginning to lose my patience. The next several months will be nail biters for me, but I have sure felt high today. I found this info on FDA's website, www.fda.gov, and did a search on "Priority review process". The answer, under the first hit, covered Fast Track, Accelerated Approval, and Priority Review.
After reading this news today, I went to the FDA's site and looked up what exactly they mean by "Priority review". VX 950 (Telaprevir) has been on Fast Track for at least a year, and under this program FDA and the drug companies work more closely together than is normal to facilitate the submission process. The submitter can also request a priority review if the drug meets FDA's criterion. Vertex has done so, and it appears to me that they easily fit the requirements. FDA's site states that after a submitter asks for a priority review, FDA has 45 days to submit the new drug for review. Then the FDA has an upper limit of 6 months to either reject or approve the request for approval. One of the articles that I read today seemed to hint that this priority review will take the full 6 months, and it may, but it can also possibly be finished in less time. FDA's site used as an example "Pegasys" ( I guess we're all familiar with this one). Pegasys was granted a priority review, and it was approved in only 4 months! I'm hoping for the best, because after nearly 6 years of watching and waiting, I'm beginning to lose my patience. The next several months will be nail biters for me, but I have sure felt high today. I found this info on FDA's website, www.fda.gov, and did a search on "Priority review process". The answer, under the first hit, covered Fast Track, Accelerated Approval, and Priority Review.
Short-Course Telaprevir Equal to Full-Course in Some Patients With HCV
November 8, 2010 (Boston, Massachusetts) — Treatment of hepatitis C virus (HCV) infection with the protease inhibitor telaprevir added to a standard of care regimen of pegylated interferon alfa-2a plus ribavirin can be shortened from 48 weeks to 24 weeks in patients with an extended rapid viral response (eRVR), according to data presented here at The Liver Meeting 2010: American Association for the Study of Liver Diseases (AASLD) 61st Annual Meeting.
ILLUMINATE was a multicenter phase 3 open-label study in genotype 1 treatment-naïve patients that used guided duration of treatment to determine the length of the regimen. Principal investigator Kenneth E. Sherman, MD, from the University of Cincinnati College of Medicine in Ohio, delivered the results.
Patients received 12 weeks of telaprevir (750 mg every 8 hours) added to peginterferon alfa-2a (180 μg/week) and weight-based ribavirin (standard of care). Those who achieved an eRVR (undetectable HCV RNA at weeks 4 and 12) were randomized at week 20 to receive an additional 4 weeks or 28 weeks of telaprevir plus standard of care, for a total of 24 or 48 weeks of treatment. Patients who did not meet the eRVR criteria received a standard 48-week course of therapy.
The primary end point was sustained virologic response (SVR) below 25 copies/mL (TaqMan assay) 24 weeks after completion of the regimen. The margin of noninferiority was predefined as –10.5% on intent-to-treat analysis.
Dr. Sherman said stopping rules included discontinuation of telaprevir in those who had HCV RNA levels above 1000 copies/mL at week 4 and continuation of standard of care.
At week 12, "those who failed to achieve at least a 2 log drop from baseline were discontinued on all study drugs and classified as a nonresponders. Between weeks 24 and 36, any patient with a detectable HCV RNA level discontinued all study drugs."
ILLUMINATE involved 540 patients. Of these, 100 discontinued treatment for a variety of reasons before reaching week 20, when randomization was done.
In all, 322 (65%) achieved eRVR (72% on intent-to-treat analysis) and were randomized to either 24 or 48 weeks of telaprevir treatment. SVR was achieved in 92% and 88%, respectively, Dr. Sherman reported.
"There was a positive 4.5% increase in the shorter therapy period; clearly, that was within the noninferiority range," he added. There was no statistical difference between the 2 groups in terms of relapse.
Turning to factors that traditionally predict a poorer response, Dr. Sherman said patients with hepatic fibrosis and cirrhosis showed "quite a respectable 63%" in SVR. "Among those who achieved eRVR, there was no difference between the groups, and no difference between 24 and 48 weeks of therapy," he reported.
There continues to be differences in responses along the lines of race/ethnicity, "but among those who achieved eRVR, there was no difference in response based on race or ethnicity."
Adverse events were those commonly seen in patients treated with the backbone of interferon and ribavirin. Rash attributed to telaprevir was a principle difference, with 63% of patients experiencing some degree of rash and 7% experiencing severe rash. It resolved upon discontinuation or completion of telaprevir. Discontinuation of all drugs for all causes was 7%; rash and anemia each caused 1% of discontinuations.
"Overall, due to any adverse event, 12% discontinued use of telaprevir; rash events constituted 7% and anemia events 2%," he said. There was a 17% discontinuation of all drugs because of adverse events. The rates were similar to those seen in other phase 2 and 3 trials of telaprevir.
Dr. Sherman concluded that there was "no clinical benefit to extending telaprevir-based therapy beyond 24 weeks in patients with eRVR, [which comprised] two thirds of the study patients. All study patients, regardless of liver fibrosis stage, race, or ethnicity, achieved high SVR rates with response-guided therapy."
In response to a question on resistance from the audience, he said that "breakthrough was observed in 1% to 3% of patients who were in the eRVR groups. The resistance patterns are similar to what has been seen previously in patients who do not ultimately clear" the virus, Dr. Sherman responded.
Conference chair Arun Sanyal, MD, from the Medical College of Virginia in Richmond, called the rates of response "incredible when you think about the time when we only had a 5% response rate to interferon." It represents another big step forward in our ability to treat HCV infection, he asserted.
Vertex/Johnson & Johnson sponsored the ILLUMINATE study. Dr. Sherman reports research funding and consulting ties to the company. Dr. Sanyal reports research and consulting ties to other companies developing HCV drugs.
The Liver Meeting 2010: American Association for the Study of Liver Diseases (AASLD) 61st Annual Meeting: Abstract LB-2 Presented November 1, 2010.
November 8, 2010 (Boston, Massachusetts) — Treatment of hepatitis C virus (HCV) infection with the protease inhibitor telaprevir added to a standard of care regimen of pegylated interferon alfa-2a plus ribavirin can be shortened from 48 weeks to 24 weeks in patients with an extended rapid viral response (eRVR), according to data presented here at The Liver Meeting 2010: American Association for the Study of Liver Diseases (AASLD) 61st Annual Meeting.
ILLUMINATE was a multicenter phase 3 open-label study in genotype 1 treatment-naïve patients that used guided duration of treatment to determine the length of the regimen. Principal investigator Kenneth E. Sherman, MD, from the University of Cincinnati College of Medicine in Ohio, delivered the results.
Patients received 12 weeks of telaprevir (750 mg every 8 hours) added to peginterferon alfa-2a (180 μg/week) and weight-based ribavirin (standard of care). Those who achieved an eRVR (undetectable HCV RNA at weeks 4 and 12) were randomized at week 20 to receive an additional 4 weeks or 28 weeks of telaprevir plus standard of care, for a total of 24 or 48 weeks of treatment. Patients who did not meet the eRVR criteria received a standard 48-week course of therapy.
The primary end point was sustained virologic response (SVR) below 25 copies/mL (TaqMan assay) 24 weeks after completion of the regimen. The margin of noninferiority was predefined as –10.5% on intent-to-treat analysis.
Dr. Sherman said stopping rules included discontinuation of telaprevir in those who had HCV RNA levels above 1000 copies/mL at week 4 and continuation of standard of care.
At week 12, "those who failed to achieve at least a 2 log drop from baseline were discontinued on all study drugs and classified as a nonresponders. Between weeks 24 and 36, any patient with a detectable HCV RNA level discontinued all study drugs."
ILLUMINATE involved 540 patients. Of these, 100 discontinued treatment for a variety of reasons before reaching week 20, when randomization was done.
In all, 322 (65%) achieved eRVR (72% on intent-to-treat analysis) and were randomized to either 24 or 48 weeks of telaprevir treatment. SVR was achieved in 92% and 88%, respectively, Dr. Sherman reported.
"There was a positive 4.5% increase in the shorter therapy period; clearly, that was within the noninferiority range," he added. There was no statistical difference between the 2 groups in terms of relapse.
Turning to factors that traditionally predict a poorer response, Dr. Sherman said patients with hepatic fibrosis and cirrhosis showed "quite a respectable 63%" in SVR. "Among those who achieved eRVR, there was no difference between the groups, and no difference between 24 and 48 weeks of therapy," he reported.
There continues to be differences in responses along the lines of race/ethnicity, "but among those who achieved eRVR, there was no difference in response based on race or ethnicity."
Adverse events were those commonly seen in patients treated with the backbone of interferon and ribavirin. Rash attributed to telaprevir was a principle difference, with 63% of patients experiencing some degree of rash and 7% experiencing severe rash. It resolved upon discontinuation or completion of telaprevir. Discontinuation of all drugs for all causes was 7%; rash and anemia each caused 1% of discontinuations.
"Overall, due to any adverse event, 12% discontinued use of telaprevir; rash events constituted 7% and anemia events 2%," he said. There was a 17% discontinuation of all drugs because of adverse events. The rates were similar to those seen in other phase 2 and 3 trials of telaprevir.
Dr. Sherman concluded that there was "no clinical benefit to extending telaprevir-based therapy beyond 24 weeks in patients with eRVR, [which comprised] two thirds of the study patients. All study patients, regardless of liver fibrosis stage, race, or ethnicity, achieved high SVR rates with response-guided therapy."
In response to a question on resistance from the audience, he said that "breakthrough was observed in 1% to 3% of patients who were in the eRVR groups. The resistance patterns are similar to what has been seen previously in patients who do not ultimately clear" the virus, Dr. Sherman responded.
Conference chair Arun Sanyal, MD, from the Medical College of Virginia in Richmond, called the rates of response "incredible when you think about the time when we only had a 5% response rate to interferon." It represents another big step forward in our ability to treat HCV infection, he asserted.
Vertex/Johnson & Johnson sponsored the ILLUMINATE study. Dr. Sherman reports research funding and consulting ties to the company. Dr. Sanyal reports research and consulting ties to other companies developing HCV drugs.
The Liver Meeting 2010: American Association for the Study of Liver Diseases (AASLD) 61st Annual Meeting: Abstract LB-2 Presented November 1, 2010.
I suspect people like us will do at least a total of 48 weeks don't you? That duration doesn't even bother me. I could do that with one hand tied behind my back!
Trin
Trin
It will be greater news when I can finally get my paws on it. Still wondering what different doctors will recommend as far as treatment time (months). Seems I've heard numerous answers on this and still can't get a final answer. Anyone?
Magnum
Magnum
"Vertex was granted Fast Track designation by the FDA for telaprevir in 2005. In mid-2010, as part of the Fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete"
I hope this is the start of something grand! Someone had posted the timeline for FDA approval but I don't remember it. Hope it is soon.... I wonder how many people will treat in 2011 when these new drugs bust loose. Thanks for posting this ny!
frijole
I hope this is the start of something grand! Someone had posted the timeline for FDA approval but I don't remember it. Hope it is soon.... I wonder how many people will treat in 2011 when these new drugs bust loose. Thanks for posting this ny!
frijole
This was inforfrom yahoo finance in an article on Vertex filing;
Highlights of the Telaprevir Phase 3 Data Included in the Submission
All Phase 3 studies met their primary endpoints and results below are from the treatment arms where telaprevir was started immediately in combination with pegylated-interferon and ribavirin for the first 12 weeks of treatment.
In people with hepatitis C who were new to treatment (treatment-naïve):
Up to 75% achieved a viral cure with telaprevir-based combination therapy, compared to 44% of people who received pegylated-interferon and ribavirin alone;
A majority (58% in ADVANCE and 65% in ILLUMINATE) were eligible to reduce their treatment time by half – from 48 weeks to 24 weeks; and
Data showed there was no benefit to extending total treatment from 24 weeks to 48 weeks in people whose virus was undetectable at weeks 4 and 12 with telaprevir-based therapy.
In the three major subgroups of people with hepatitis C who had not achieved a viral cure with a prior course of treatment (treatment-experienced):
83% of prior relapsers, 59% of prior partial responders and 29% of prior null responders achieved a viral cure with telaprevir-based combination therapy compared to 24%, 15%, and 5% of people in these subgroups, respectively, who received pegylated-interferon and ribavirin alone. These results were achieved with a simultaneous start of all three drugs for the first 12 weeks followed by pegylated-interferon and ribavirin alone for an additional 36 weeks.
The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment arm were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.
Highlights of the Telaprevir Phase 3 Data Included in the Submission
All Phase 3 studies met their primary endpoints and results below are from the treatment arms where telaprevir was started immediately in combination with pegylated-interferon and ribavirin for the first 12 weeks of treatment.
In people with hepatitis C who were new to treatment (treatment-naïve):
Up to 75% achieved a viral cure with telaprevir-based combination therapy, compared to 44% of people who received pegylated-interferon and ribavirin alone;
A majority (58% in ADVANCE and 65% in ILLUMINATE) were eligible to reduce their treatment time by half – from 48 weeks to 24 weeks; and
Data showed there was no benefit to extending total treatment from 24 weeks to 48 weeks in people whose virus was undetectable at weeks 4 and 12 with telaprevir-based therapy.
In the three major subgroups of people with hepatitis C who had not achieved a viral cure with a prior course of treatment (treatment-experienced):
83% of prior relapsers, 59% of prior partial responders and 29% of prior null responders achieved a viral cure with telaprevir-based combination therapy compared to 24%, 15%, and 5% of people in these subgroups, respectively, who received pegylated-interferon and ribavirin alone. These results were achieved with a simultaneous start of all three drugs for the first 12 weeks followed by pegylated-interferon and ribavirin alone for an additional 36 weeks.
The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment arm were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.
Buy stock now while its 30 something a share!!I did!!!With the advice of a broker that is.But also great news-I knew my Dr knew something when he told me that Vertex was hiring more people to get ready for the "Slam"
I myself am waiting for these to become available-The timing is great.I just hope that they dont say you must have failed another tx first.I dont want to do this but 1 time !!!
I myself am waiting for these to become available-The timing is great.I just hope that they dont say you must have failed another tx first.I dont want to do this but 1 time !!!
Will they make us President's for being around for so long Willy? ;)
I agree going to be flooded once all the warehoused patients alone are seeking treatment. If they can get the word out that people should test.......wow going to be zillions of heppers everywhere!
I agree going to be flooded once all the warehoused patients alone are seeking treatment. If they can get the word out that people should test.......wow going to be zillions of heppers everywhere!
Thanks for posting this. I think it's a milestone of sorts. It signals the end of the required hurdles that Vertex needed to jump through for approval. We'll now see if the FDA agrees. I've had somewhat informed people tell me that it was a done deal several years ago before Phase 3 started dosing. Since then no safety issues have raised their heads that I'm aware of. The only thing that has changed is their success rate has increased, the dropout rate has lessened a bit and the number of people dosed with Telaprevir has now exceeded over 2000 people.
It's amazing to think that people could be dosing in the next 6-9 months. If so, this forum is going to get flooded with people on TX, wouldn't you think?
willy
It's amazing to think that people could be dosing in the next 6-9 months. If so, this forum is going to get flooded with people on TX, wouldn't you think?
willy
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