Aa
FDA PANELS THIS WEEK
This is our week. April 27 the US FDA advisory panel meets to review bocerprevir. The next day, April 28, the same panel meets to review telaprevir. The FDA is supposed to publish a reveiw of both on Monday, April 25, posted to their website:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/ucm247236.htm
These panels should show us what questions or concerns are being raised by the FDA. The advisory panel does not approve or reject the drug but this panel of experts will recommend or not recommend the drugs for FDA approval. The announcement for Merck's boceprevir approval is expected on May 7 and the announcement for Vertex is set for May 23.
Now I know there are those who scorn news from the investment end of the research , but I figure, get the news where you can. There is an analyst who is going to live blog both days. (they both start at 7:45 eastern time). He has a link so you can leave an email address for a reminder of his live blog. He has apparently done this before with many drugs awaiting FDA approval. I looked on the FDA website and found infromation on attending the event, but not anywhere can you follow it through the FDA site. Therefore, this may be our only insight into the meeting - real time. Here is his article and in it, on pages 2 and 3 there are little boxes to put in your email address to be reminded of both blogs. Hopefully they will provide the link in. I have never done this before but I hope it works.
http://www.thestreet.com/story/11089849/merck-vertex-prepare-for-hep-c-drug-panels.html
frijole
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/ucm247236.htm
These panels should show us what questions or concerns are being raised by the FDA. The advisory panel does not approve or reject the drug but this panel of experts will recommend or not recommend the drugs for FDA approval. The announcement for Merck's boceprevir approval is expected on May 7 and the announcement for Vertex is set for May 23.
Now I know there are those who scorn news from the investment end of the research , but I figure, get the news where you can. There is an analyst who is going to live blog both days. (they both start at 7:45 eastern time). He has a link so you can leave an email address for a reminder of his live blog. He has apparently done this before with many drugs awaiting FDA approval. I looked on the FDA website and found infromation on attending the event, but not anywhere can you follow it through the FDA site. Therefore, this may be our only insight into the meeting - real time. Here is his article and in it, on pages 2 and 3 there are little boxes to put in your email address to be reminded of both blogs. Hopefully they will provide the link in. I have never done this before but I hope it works.
http://www.thestreet.com/story/11089849/merck-vertex-prepare-for-hep-c-drug-panels.html
frijole
I cannot wait for you to be SVR Frijole you were one of the first friends I made on here .... and I still have my little bug doll right on the tv so I do think of you often :D
"So maybe you will see more of me soon."
Hope so.
I'd vote not treating in the height of the summer where you live.
Hope so.
I'd vote not treating in the height of the summer where you live.
Yes, I am watching. I don't know if I should wait until December when it would be 3 years from my last biopsy or jump in this summer. It is not much fun deciding which year of my life I want to lose again. The clinic where I consulted after I relapsed called a week or two ago but I haven't returned the call yet. I haven't been to see any doc about C for two years.
I am leaning to telaprevir, mainly because of the anemia issue. Since I was anemic most of the prior treament, I would surely be more anemic with boceprevir. Also I have never had skin problems to speak of so don't think I would be one of the 5% who got the telaprevir rash.
I guess one thing I need to be clear on is what the labels way about treatment time and when VL testing should be done. I think it will have to be at 2 weeks after the PI is given. Then, of course 4 and 12 and the usual. For example, if you are clear by sensitive test at week 2, can you treat for 24 weeks? What a dream, huh? There are some pretty significant issues that may not filter down to the lowly GI's who could care less about treating for C -- and I would prefer treating locally more than treating in Dallas - a 6 hour drive away.
So maybe you will see more of me soon.
frijole
I am leaning to telaprevir, mainly because of the anemia issue. Since I was anemic most of the prior treament, I would surely be more anemic with boceprevir. Also I have never had skin problems to speak of so don't think I would be one of the 5% who got the telaprevir rash.
I guess one thing I need to be clear on is what the labels way about treatment time and when VL testing should be done. I think it will have to be at 2 weeks after the PI is given. Then, of course 4 and 12 and the usual. For example, if you are clear by sensitive test at week 2, can you treat for 24 weeks? What a dream, huh? There are some pretty significant issues that may not filter down to the lowly GI's who could care less about treating for C -- and I would prefer treating locally more than treating in Dallas - a 6 hour drive away.
So maybe you will see more of me soon.
frijole
So, you're watching with interest. Does that mean that you expect to be jumping back into the fray in the near future? At this point are you leaning towards one or the other as your prom date. Oh yeah, congratualtions on makeing it through another season !
By JENNIFER CORBETT DOOREN
A Food and Drug Administration staff review of Merck & Co.'s proposed hepatitis C drug boceprevir has raised safety concerns about anemia and other blood disorders.
But the review also said it agreed with Merck's analysis showing adding boceprevir to other drugs currently used to treat hepatitis C was significantly more effective at treating the condition. Broadly, two studies submitted to the FDA in support of boceprevir showed more patients responded to treatment by achieving a so-called sustained virologic response. However, certain groups such as African-Americans and patients with more advanced hepatitis C didn't respond as well.
Boceprevir faces a review by the FDA's Antiviral Drugs Advisory Committee on Wednesday. A similar product, telaprevir, from Vertex Pharmaceuticals Inc., will be reviewed by the panel on Thursday. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease. Both drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate.
Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is spread when the blood of an infected person enters the body of someone previously not infected. The Centers for Disease Control and Prevention said most people become infected by sharing needles or other equipment used to inject drugs, although the agency said people who receive body piercings or tattoos with nonsterile instruments are also at risk of becoming infected with hepatitis C. About 3.2 million Americans are infected with hepatitis C.
The FDA posted a review of boceprevir on its website on Monday. The main safety issue the agency raised with regard to boceprevir was an "increased frequency and severity of anemia" or a decrease in the number of red blood cells when boceprevir is added to pegylated interferon and ribavirin, two other drugs currently used to treat hepatitis C.
The agency also said there was an increased number of reported psychiatric symptoms of "suicidal and homicidal ideation" in the boceprevir arms of the studies compared to the control groups. However, the FDA said "it is difficult to make any meaningful clinical conclusions from this observation." Reports of suicidal ideation occurred in fewer than 1% of patients in the studies.
The FDA advisory panel is being asked to vote on whether it thinks the available data support the approval of boceprevir. The vote will amount to a recommendation about whether the panel thinks the agency should approve the product. The FDA is not required to follow the advice of its advisory panels but usually does.
The panel will also be asked to discuss whether certain patients, such as African-Americans, should receive longer therapy with boceprevir.
Merck, in a document also posted on FDA's website, said boceprevir "fulfils a significant unmet medical need" for the treatment of hepatitis C infection. Merck has proposed a brand name of Victrelis for boceprevir.
Write to Jennifer Corbett Dooren at jennifer.corbett-***@****
Copyright 2011 Dow Jones & Company, Inc. All Rights Reserved
This copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit
www.djreprints.com
More In Health Join the discussion Be the first to commentMore In Health »
EmailPrinter FriendlyOrder ReprintsShare: facebook
Twitter
LinkedIn
StumbleUpon
Viadeo
Orkut
Fark
Reddit
del.icio.us
MySpace
A Food and Drug Administration staff review of Merck & Co.'s proposed hepatitis C drug boceprevir has raised safety concerns about anemia and other blood disorders.
But the review also said it agreed with Merck's analysis showing adding boceprevir to other drugs currently used to treat hepatitis C was significantly more effective at treating the condition. Broadly, two studies submitted to the FDA in support of boceprevir showed more patients responded to treatment by achieving a so-called sustained virologic response. However, certain groups such as African-Americans and patients with more advanced hepatitis C didn't respond as well.
Boceprevir faces a review by the FDA's Antiviral Drugs Advisory Committee on Wednesday. A similar product, telaprevir, from Vertex Pharmaceuticals Inc., will be reviewed by the panel on Thursday. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease. Both drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate.
Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is spread when the blood of an infected person enters the body of someone previously not infected. The Centers for Disease Control and Prevention said most people become infected by sharing needles or other equipment used to inject drugs, although the agency said people who receive body piercings or tattoos with nonsterile instruments are also at risk of becoming infected with hepatitis C. About 3.2 million Americans are infected with hepatitis C.
The FDA posted a review of boceprevir on its website on Monday. The main safety issue the agency raised with regard to boceprevir was an "increased frequency and severity of anemia" or a decrease in the number of red blood cells when boceprevir is added to pegylated interferon and ribavirin, two other drugs currently used to treat hepatitis C.
The agency also said there was an increased number of reported psychiatric symptoms of "suicidal and homicidal ideation" in the boceprevir arms of the studies compared to the control groups. However, the FDA said "it is difficult to make any meaningful clinical conclusions from this observation." Reports of suicidal ideation occurred in fewer than 1% of patients in the studies.
The FDA advisory panel is being asked to vote on whether it thinks the available data support the approval of boceprevir. The vote will amount to a recommendation about whether the panel thinks the agency should approve the product. The FDA is not required to follow the advice of its advisory panels but usually does.
The panel will also be asked to discuss whether certain patients, such as African-Americans, should receive longer therapy with boceprevir.
Merck, in a document also posted on FDA's website, said boceprevir "fulfils a significant unmet medical need" for the treatment of hepatitis C infection. Merck has proposed a brand name of Victrelis for boceprevir.
Write to Jennifer Corbett Dooren at jennifer.corbett-***@****
Copyright 2011 Dow Jones & Company, Inc. All Rights Reserved
This copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit
www.djreprints.com
More In Health Join the discussion Be the first to commentMore In Health »
EmailPrinter FriendlyOrder ReprintsShare: facebook
StumbleUpon
Viadeo
Orkut
Fark
del.icio.us
MySpace
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
