Aa
Protease Inhibitors and the FDA
Because of my persistence, I received three phone calls from the FDA today. I'm going to now present you with the clarity of what's about to happen with the "Rolling NDA" (New Drug Application) from Vertex and other pharmaceutical companies.
A Rolling NDA is an application to have the FDA put this drug on a “Priority Approval” as opposed to a “Standard Approval”. Here's the difference. A Standard Approval (by the FDA) means that the maximum amount of time the FDA can take in approving a new drug is 10 months. A Priority Approval means the FDA has to either approve or not approve a new drug within a maximum amount of time no greater than 6 months.
Vertex is submitting a Rolling NDA for Telaprevir. This means that if they file for it with the FDA this month, it can be approved by the end of this year and we could initially get the drug in January, 2011.
However, there is a catch: the Rolling NDA may come in in pieces. By this, the FDA says that the pharmaceutical companies may present clinical trial results in bits and pieces. In that case, the FDA has to wait until the entire package (all data) on the drug has been received before they can start the Priority Approval. So, if the pieces of data trickle in until the end of this year, it could take 6 months from that time (when all data has been received) that the FDA will star the Priority Approval process. In that case, the drug may not be available until mid 2011.
I have made good contacts with Vertex and the FDA and will stay on top of this. I believe being proactive and a pain in the *** can sometimes put a fire under their *** so they will not forget us. That’s my mission and it should also be yours.
One more thing, and this is where you all can help. When an important “viral” drug is to be scrutinized by the FDA (as the AIDS drugs were), the FDA has a division called the “Advisory Committee”. Their job is to revue the urgency of a new drug based on the input they receive from the public and from doctors. So my friends, let’s keep calling the FDA at least on a weekly basis. I left numbers on my former posts.
I was told that one reason why the FDA is being cautious with a new drug, is the fact that as in some of the AIDS drugs, there could be a resistance. That also has to be presented in the clinical trials results. Then that concern goes to the Advisory Committee for scrutiny. Keep your fingers crossed that the pieces of the puzzle fall together in place quickly...
Magnum
A Rolling NDA is an application to have the FDA put this drug on a “Priority Approval” as opposed to a “Standard Approval”. Here's the difference. A Standard Approval (by the FDA) means that the maximum amount of time the FDA can take in approving a new drug is 10 months. A Priority Approval means the FDA has to either approve or not approve a new drug within a maximum amount of time no greater than 6 months.
Vertex is submitting a Rolling NDA for Telaprevir. This means that if they file for it with the FDA this month, it can be approved by the end of this year and we could initially get the drug in January, 2011.
However, there is a catch: the Rolling NDA may come in in pieces. By this, the FDA says that the pharmaceutical companies may present clinical trial results in bits and pieces. In that case, the FDA has to wait until the entire package (all data) on the drug has been received before they can start the Priority Approval. So, if the pieces of data trickle in until the end of this year, it could take 6 months from that time (when all data has been received) that the FDA will star the Priority Approval process. In that case, the drug may not be available until mid 2011.
I have made good contacts with Vertex and the FDA and will stay on top of this. I believe being proactive and a pain in the *** can sometimes put a fire under their *** so they will not forget us. That’s my mission and it should also be yours.
One more thing, and this is where you all can help. When an important “viral” drug is to be scrutinized by the FDA (as the AIDS drugs were), the FDA has a division called the “Advisory Committee”. Their job is to revue the urgency of a new drug based on the input they receive from the public and from doctors. So my friends, let’s keep calling the FDA at least on a weekly basis. I left numbers on my former posts.
I was told that one reason why the FDA is being cautious with a new drug, is the fact that as in some of the AIDS drugs, there could be a resistance. That also has to be presented in the clinical trials results. Then that concern goes to the Advisory Committee for scrutiny. Keep your fingers crossed that the pieces of the puzzle fall together in place quickly...
Magnum
Sorry about interrupting the thread. I thougt I was posting in another thread.- Dave.
Good work nice to get the latest updates, Not sure if I will retreat or not ,my Hep C and I are friends now that I don't antagonize it as much
cheers
cheers
They have doubled the success rate, It is a huge step in the right direction and they will undoubtedly save many lives.
I waited 12 years to treat since diagnosis. I didn't like the idea of running around with this virus in me, but the fact that I had no fibrosis and no cryo and several discussions with some very good doctors convinced me that I should wait for better drugs.
I would still think seriously about waiting for even better drugs if my doctors felt I could afford to wait. My hepatologist said it was time to treat mainly because of the cryo and I was lucky enough to find a study that accepted me.
I waited 12 years to treat since diagnosis. I didn't like the idea of running around with this virus in me, but the fact that I had no fibrosis and no cryo and several discussions with some very good doctors convinced me that I should wait for better drugs.
I would still think seriously about waiting for even better drugs if my doctors felt I could afford to wait. My hepatologist said it was time to treat mainly because of the cryo and I was lucky enough to find a study that accepted me.
There have been a lot of people who have SVR'd with the Protease Inhibitors!!! I can't wait until they get approved.
You have my vote. Your doing an incredible job with it. The pressure works. The squeaky wheel theory is proved over and over.
Hahaha. Very clever. Whatever it takes my friend, whatever it takes. I got tired of sitting on the sidelines and at this point, pressure applied in the right place and in a constant matter can make a big difference. As I stated before, and as the FDA also admitted today, they are constantly involved in a maelstrom of drugs to approve or not. Therefore, the pressure so they won’t forget us...
Magnum for Congress
Magnum for Congress
I can just see the headlines!
"Man with HCV and liver disease Magnum breaks into congressional session dressed as an HCV viron" won't take no for an answer on PI's"
"magnum marches on washington"
"Man with HCV and liver disease Magnum breaks into congressional session dressed as an HCV viron" won't take no for an answer on PI's"
"magnum marches on washington"
That's consistent with what data I've found as well. Great information Magnum!!
Telaprevir is the direct-acting oral HCV agent furthest along in development; Vertex has indicated that it expects to request U.S. regulatory approval in the second half of 2010.
Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for telaprevir in the second half of 2010 for both treatment-naive and treatment-failure patients.
http://www.hivandhepatitis.com/hep_c/news/2010/0608_2010_a.html
Owing to their novel mechanisms of action (HCV protease inhibition) and the need for new hepatitis C virus therapies, both telaprevir and boceprevir are likely therapeutic options for prior treatment nonresponders. However, due to potentially shorter treatment duration for some patients and proven efficacy in treatment nonresponders, telaprevir may likely be viewed more positively by clinicians than boceprevir, following the expected launches of both drugs in 2011 in the United States.
http://www.news-medical.net/news/20100120/Telaprevir-effective-in-HCV-patients.aspx
Telaprevir is the direct-acting oral HCV agent furthest along in development; Vertex has indicated that it expects to request U.S. regulatory approval in the second half of 2010.
Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for telaprevir in the second half of 2010 for both treatment-naive and treatment-failure patients.
http://www.hivandhepatitis.com/hep_c/news/2010/0608_2010_a.html
Owing to their novel mechanisms of action (HCV protease inhibition) and the need for new hepatitis C virus therapies, both telaprevir and boceprevir are likely therapeutic options for prior treatment nonresponders. However, due to potentially shorter treatment duration for some patients and proven efficacy in treatment nonresponders, telaprevir may likely be viewed more positively by clinicians than boceprevir, following the expected launches of both drugs in 2011 in the United States.
http://www.news-medical.net/news/20100120/Telaprevir-effective-in-HCV-patients.aspx
Thanks for your tenacity. It reminds me of the saying that snapping turtles won't let go until it thunders.
In appreciation,
Ev
In appreciation,
Ev
Awesome information Magnum. You are really getting some information out of the bureaucrats. I guess we all expected the resistance to be an issue with the fda. We should still be able to make the choices to use these new drugs for ourselves when the alternative is serious illness or death.
- Dave
- Dave
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