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Telaprevir Launch..........
Has anyone heard if and when Teleprevir will Launch in the US? I am from Canada...............Was UND at the end of my treatment and Post TX...... have relapsed..........now have to wait for the new Meds in Canada to be approved.........I have a specialist that I will call............interesting..and cannot seem to get any straight answers about anything
Thanks all!
Thanks all!
Hi i joined a 7 day FREE trial with Pharmaletter on the internet this will give updated information on Telaprevir and Bocaprevir.
Copied and pasted below is the latest on Telaprevir printed 11th Jan 2011
Website} http://www.thepharmaletter.com
Sign up for 7 day free trial in the next few months as if you join now what is listed below is the latest.
Priority reviews for Vertex’ hep C candidate telaprevir in USA and Canada
Article | 21 January 2011
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USA-based Vertex Pharmaceuticals (Nasdaq: VRTX) said yesterday that the Food and Drug Administration has accepted the New Drug Application for telaprevir and granted the company's request for six-month Priority Review.
Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.
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Additionally, Vertex announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
Back in race to market with Merck & Co’s boceprevir
Vertex is in a race to the hepatitis C market - expected to reach a value of $7.5 billion by 2014 - with Merck & Co, which recently moved into the lead with being granted expedited review of its boceprevir in both the USA and European Union (The Pharma Letter January 7).
In December 2010, partner Janssen-Cilag International NV, part of US drugs giant Johnson & Johnson (NYSE: JNJ) announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
"Data from Phase III studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, chief scientific officer and executive vice president of global R&D at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."
Data to support the telaprevir submissions
The regulatory submissions in the USA, Canada and Europe are supported by data from three Phase III studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75% of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months - half the time needed with currently available medicines.
Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase III data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase III studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity
Copied and pasted below is the latest on Telaprevir printed 11th Jan 2011
Website} http://www.thepharmaletter.com
Sign up for 7 day free trial in the next few months as if you join now what is listed below is the latest.
Priority reviews for Vertex’ hep C candidate telaprevir in USA and Canada
Article | 21 January 2011
• Print This
• ShareThis
USA-based Vertex Pharmaceuticals (Nasdaq: VRTX) said yesterday that the Food and Drug Administration has accepted the New Drug Application for telaprevir and granted the company's request for six-month Priority Review.
Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.
Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here.
Additionally, Vertex announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
Back in race to market with Merck & Co’s boceprevir
Vertex is in a race to the hepatitis C market - expected to reach a value of $7.5 billion by 2014 - with Merck & Co, which recently moved into the lead with being granted expedited review of its boceprevir in both the USA and European Union (The Pharma Letter January 7).
In December 2010, partner Janssen-Cilag International NV, part of US drugs giant Johnson & Johnson (NYSE: JNJ) announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
"Data from Phase III studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, chief scientific officer and executive vice president of global R&D at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."
Data to support the telaprevir submissions
The regulatory submissions in the USA, Canada and Europe are supported by data from three Phase III studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75% of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months - half the time needed with currently available medicines.
Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase III data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase III studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity
Vertex filed the NDA in November and asked for an expedited review. If the get the expedited review, and they probably will, the maximum at will take is 6 months from the date of filing; that makes it sometime in May. It could happen sooner than that, but no one should count on it.
The worst case -- they get denied the expedited review, the process takes a maximum of 10 months. I have no idea what the rules are in Canada.
Vertex is hiring a sales force, according to the financial news reports.
The worst case -- they get denied the expedited review, the process takes a maximum of 10 months. I have no idea what the rules are in Canada.
Vertex is hiring a sales force, according to the financial news reports.
yeah....I hate this stupid disease too!!!!Became quite ill...hence disappeared for awhile. The wost part was this.........person called me, said.GODD news!! You are UND.......not 5 mins later, phoned back and said, sorry to break this to you but we read the wrong test results.........and the virus has resurfaced..........good god, asked what to do in the mean time, could not get an answer, .......hate not having any direction..................I am hoping Canada can get on the bandwagon shortly after the US.............I have not given up yet, just trying to pick myself up....dust myself off.....and prepare to do battle again!
Hey how are you it's nice to see you again but I am SO SO Sorry Isaldy that really *****, that is so not fair. I hate this dumb disease so much. I'm just so sorry to hear that.
They are saying it could be as early as summer of 2011 - we are really hoping so but of course there is no guarantee of anything.
They are saying it could be as early as summer of 2011 - we are really hoping so but of course there is no guarantee of anything.
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