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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
chair is summarizing question 1 -- consensus is that while concerns raised about hematological effects of BOC they are well managed...
adam feuerstein: here are the voting questions:
1. Please comment on the safety of boceprevir in patients with chronic hepatitis C genotype 1, focusing mainly on the hematological effects of boceprevir in combination with pegylated interferon and ribavirin (PR).
2. Considering the overall potential risk and benefits of boceprevir, do the available data support approval of boceprevir for treatment of patients with chronic hepatitis C genotype 1 in combination with pegylated interferon and ribavirin?
VOTE: Yes/No/Abstain
a.
If no, what additional studies are recommended?
b.
If yes, proceed with the remaining questions.
3. Please comment on the strength of the evidence for use of boceprevir in combination with pegylated interferon/ribavirin in prior null responders (defined as less than 2 log10 decrease in HCV RNA at 12 weeks during previous course of PR therapy), who were not included in the Phase 3 trial, P5101 in subjects who had previously failed PR therapy.
4. Please comment on the strength of the evidence to support response-guided therapy (RGT) with boceprevir in combination with pegylated interferon and ribavirin. Should certain groups of patients receive longer durations of boceprevir plus PR therapy than that evaluated in RGT arms?
a. Treatment-naïve patients with detectable HCV RNA at Week 8 and undetectable at Week 24 (late responders)
b. Patients such as blacks or those with advanced fibrosis or cirrhosis
c. Null responders (if recommended for inclusion in the indication)
d. Other groups, such as patients with poor interferon responsiveness (i.e. < 1 log10 HCV RNA decline after the 4 week lead-in therapy with PR)
5. In addition to pediatric studies, are there any other postmarketing studies you would recommend to further define risks or optimal use of boceprevir in clinical practice?
1. Please comment on the safety of boceprevir in patients with chronic hepatitis C genotype 1, focusing mainly on the hematological effects of boceprevir in combination with pegylated interferon and ribavirin (PR).
2. Considering the overall potential risk and benefits of boceprevir, do the available data support approval of boceprevir for treatment of patients with chronic hepatitis C genotype 1 in combination with pegylated interferon and ribavirin?
VOTE: Yes/No/Abstain
a.
If no, what additional studies are recommended?
b.
If yes, proceed with the remaining questions.
3. Please comment on the strength of the evidence for use of boceprevir in combination with pegylated interferon/ribavirin in prior null responders (defined as less than 2 log10 decrease in HCV RNA at 12 weeks during previous course of PR therapy), who were not included in the Phase 3 trial, P5101 in subjects who had previously failed PR therapy.
4. Please comment on the strength of the evidence to support response-guided therapy (RGT) with boceprevir in combination with pegylated interferon and ribavirin. Should certain groups of patients receive longer durations of boceprevir plus PR therapy than that evaluated in RGT arms?
a. Treatment-naïve patients with detectable HCV RNA at Week 8 and undetectable at Week 24 (late responders)
b. Patients such as blacks or those with advanced fibrosis or cirrhosis
c. Null responders (if recommended for inclusion in the indication)
d. Other groups, such as patients with poor interferon responsiveness (i.e. < 1 log10 HCV RNA decline after the 4 week lead-in therapy with PR)
5. In addition to pediatric studies, are there any other postmarketing studies you would recommend to further define risks or optimal use of boceprevir in clinical practice?
They are almost to a vote (it is 1:30 CST). The FDA live feed has been intermitten plus I am at work and cannot listen to it. Therefore, I have opted for the investment guy - Fuernstein's live blog. At least I can watch it and still do a little work (ha ha).
Biggest issues with BOC are the anemia and the fact that they have not tested on null responders. They have presented some information on null responders during the testing who were in the placebo group and then given the BOC and their response, but I gather that the FDA shut them down (since the info was not previously presented). At any rate, the jury is still out but it appears they will recommend to approve. I will be back later
frijole
Biggest issues with BOC are the anemia and the fact that they have not tested on null responders. They have presented some information on null responders during the testing who were in the placebo group and then given the BOC and their response, but I gather that the FDA shut them down (since the info was not previously presented). At any rate, the jury is still out but it appears they will recommend to approve. I will be back later
frijole
AH Dave all you had to do was let me know....you know I would have sent some out to you right away! Boy we girls tried everything to keep our hair ... but it did grow back (although not on my back thankfully!)
Anemia with triple therapy including boce is about 50% compared to about 30% in the soc group. I am certainly a supporter and thankful for boce, but the anemia is nothing to sneeze about.
the worst side effect of boce is that you might lose your back hair, so buyer beware!. Maybe deb's hair products would help but she never offered :(
Good luck and hopefully this next attempt will put this disease to bed for good.
-Dave
the worst side effect of boce is that you might lose your back hair, so buyer beware!. Maybe deb's hair products would help but she never offered :(
Good luck and hopefully this next attempt will put this disease to bed for good.
-Dave
Looks like we might take this journey together...I am a former slow responder and while it is with dread that I think of going back into "the rabbit hole" of treatment, I am thrilled to know it will now be shorter.
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