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Community is Invited to FDA Mtgs
The Food and Drug Administration will convene its Antiviral Drugs Advisory Committee on April 27 and 28, 2011 to provide advice and recommendations to the Agency on two drugs intended to treat hepatitis C.
On April 27, 2011, from 8 a.m. to 5 p.m., the Committee will discuss a new drug application (NDA) 202–258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with
a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with
peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
On April 28, 2011, the committee will discuss a new drug application (NDA) 201–917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed
indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
The meeting will be held on both days from 8 a.m. to 5 p.m. at the FDA White Oak Campus, located at
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.
Please note that visitors to the White Oak Campus must enter through Building 1, which is located at the circle at the entrance to the campus via Mahan Road from New Hampshire Avenue. (Google Maps)
FDA intends to make background material about these meetings available to the public no later than 2 business days before the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
Scroll down to the link for the Antiviral Drug Committee, and click on appropriate meeting dates.
If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
This FDA advisory committee meeting is free and open to the public without prior registration.
Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
Written submissions may be made to
Paul Tran, R.Ph
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: Paul.***@****
on or before April 14, 2011.
Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m., on April 28, 2011. Those desiring to make formal oral presentations should notify Paul Tran and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 6, 2011.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 7, 2011.
Please call the FDA Advisory Committee Information Line for up-to-date information on this meeting at
1-800-741-8138
(301-443-0572 in the Washington DC area)
Enter code: 3014512531
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Paul Tran at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability, or information about visitor parking and transportation may be accessed at: Public Meetings at the FDA White Oak Campus
Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. FDA is committed to the orderly conduct of its advisory committee meetings.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
On April 27, 2011, from 8 a.m. to 5 p.m., the Committee will discuss a new drug application (NDA) 202–258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with
a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with
peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
On April 28, 2011, the committee will discuss a new drug application (NDA) 201–917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed
indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
The meeting will be held on both days from 8 a.m. to 5 p.m. at the FDA White Oak Campus, located at
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.
Please note that visitors to the White Oak Campus must enter through Building 1, which is located at the circle at the entrance to the campus via Mahan Road from New Hampshire Avenue. (Google Maps)
FDA intends to make background material about these meetings available to the public no later than 2 business days before the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
Scroll down to the link for the Antiviral Drug Committee, and click on appropriate meeting dates.
If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
This FDA advisory committee meeting is free and open to the public without prior registration.
Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
Written submissions may be made to
Paul Tran, R.Ph
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: Paul.***@****
on or before April 14, 2011.
Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m., on April 28, 2011. Those desiring to make formal oral presentations should notify Paul Tran and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 6, 2011.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 7, 2011.
Please call the FDA Advisory Committee Information Line for up-to-date information on this meeting at
1-800-741-8138
(301-443-0572 in the Washington DC area)
Enter code: 3014512531
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Paul Tran at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability, or information about visitor parking and transportation may be accessed at: Public Meetings at the FDA White Oak Campus
Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. FDA is committed to the orderly conduct of its advisory committee meetings.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
Well, for the record, Paul Tran has my letter and has already responded back to me. He said he'd give it to the people doing the meetings. Also, I have experience with being in the Telaprevir trial as well as an interest in seeing these drugs be approved since I've had such a long time of trying to clear this thing myself. I basically suggested that BOTH of these drugs need to be approved as not everybody will be able to tolerate just the Telaprevir. There seems to be such a push towards the Telaprevir and not so much on the Boceprevir. I NEED for the Boceprevir to be approved, too! As I will not be ever doing Telaprevir again.
Susan400
Susan400
Thanks for being such a voice for this category of people. Joe doesn't want to tear down his life for a chance in the 30% 's. If HR's supplements didn't have him so stabilized, we would be in a panic. I guess we will just keep taking supplements and hanging on for the newer-new stuff.
Ev
Ev
>These meetings have nothing to do with anything except public comment on the 2 drugs >submitted for approval
exactly. And perhaps the single most significant factor regarding boce/tela approval is that many patients who have little to gain from taking those drugs will do so simply because they are in urgent need and have been offered no better choice. All the early trials of boce/tela showed the drugs were an utter failure as monotherapy. For true ifn non-responders to take the PIs amounts to repeating those experiments.
Approval of the drugs for naives, relapsers and partial responders is a slam dunk. There's piles of data demonstrating they outperform soc with minimal extra damage. However the issue of who, among warehoused pts should be taking them is unresolved. During trials, emergence of resistance could be monitored by expensive drug-co sponsored sequencing. This won't happen after approval and the decision of when to quit will be ad hoc.
The transcript from last year's FDA/DAVP hearing on expanded access to DAAs
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM213444.pdf
shows they are well aware of the problem but it also shows there is very little patient input in the process. The more they hear from real patients facing this decision in their lives the better.
exactly. And perhaps the single most significant factor regarding boce/tela approval is that many patients who have little to gain from taking those drugs will do so simply because they are in urgent need and have been offered no better choice. All the early trials of boce/tela showed the drugs were an utter failure as monotherapy. For true ifn non-responders to take the PIs amounts to repeating those experiments.
Approval of the drugs for naives, relapsers and partial responders is a slam dunk. There's piles of data demonstrating they outperform soc with minimal extra damage. However the issue of who, among warehoused pts should be taking them is unresolved. During trials, emergence of resistance could be monitored by expensive drug-co sponsored sequencing. This won't happen after approval and the decision of when to quit will be ad hoc.
The transcript from last year's FDA/DAVP hearing on expanded access to DAAs
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM213444.pdf
shows they are well aware of the problem but it also shows there is very little patient input in the process. The more they hear from real patients facing this decision in their lives the better.
You would add the brief comment on the end and would follow up with a written submission?
Now I get it.
Thanks for the clarification.
That really cleared things up for me.
Mike
Now I get it.
Thanks for the clarification.
That really cleared things up for me.
Mike
I didn't see anything in willing's comments about making an oral submission but rather a written submission and my comments are primarily relating to a written submission.
Since you're only commenting on the oral submission component of my post, I'll address that. I would agree with you that that one hour should focus on getting Telaprevir and Boceprevir approved. There is most definitely a lot riding on this for everybody and not just in the U.S. However, I also don't see the harm in adding a one or two line comment to encourage the FDA to make progress on their other initiatives in the works that will also benefit HCV patients who's needs will still not be addressed by a Tela/Boce approval. Said and done quickly in an oral submission - followed up more thoroughly in a written submission and said written submission will not take away from that one hour time allotted to the public for oral submissions. If we see differently on that, fair enough. I would add the brief comment on the end and would follow up with a written submission, personally.
Since you're only commenting on the oral submission component of my post, I'll address that. I would agree with you that that one hour should focus on getting Telaprevir and Boceprevir approved. There is most definitely a lot riding on this for everybody and not just in the U.S. However, I also don't see the harm in adding a one or two line comment to encourage the FDA to make progress on their other initiatives in the works that will also benefit HCV patients who's needs will still not be addressed by a Tela/Boce approval. Said and done quickly in an oral submission - followed up more thoroughly in a written submission and said written submission will not take away from that one hour time allotted to the public for oral submissions. If we see differently on that, fair enough. I would add the brief comment on the end and would follow up with a written submission, personally.
I agree that the new PIs will not be the solution for every Hep C patient, but if you are at all familiar with the regulatory agencies rule-making process this is not really the appropriate format to raise this issue. Also, there is only 1 hour per meeting set aside for the public to speak and in my opinion taking away the floor would be huge disservice to those who have something to offer about Telaprevir and Boceprevir specifically.
I think it's entirely appropriate to submit these things as part of a written submission and to allude to them briefly in an oral submission, particularly if then followed up with a related written submission. Squeaky wheel gets the grease. If there is a rare moment for the public to have the ear of the FDA, particularly those directly affected by HCV and the FDA is to read and hear submissions from that particular public, you take what you have available to you - particularly if there is an FDA initiative that is languishing, that would help people if it was prodded forward.
To remind the FDA that this is helpful but not the whole package is important so that they don't get laissez-faire or complacent about moving forward other initiatives now that they'll (likely) be approving Telaprevir and Boceprevir. That could happen and it seems important to remind them there is more yet to be done beyond these approvals.
To remind the FDA that this is helpful but not the whole package is important so that they don't get laissez-faire or complacent about moving forward other initiatives now that they'll (likely) be approving Telaprevir and Boceprevir. That could happen and it seems important to remind them there is more yet to be done beyond these approvals.
I don't think this meeting is about an opportunity to whine to the FDA about everything they don't like about the state of modern medicine. These meetings have nothing to do with anything except public comment on the 2 drugs submitted for approval. What possible good can it do to consume any of the limited time for public comment to "remind the powers that be that approval will still exclude a lot of hcv patients"?
Thanks for the name. I wrote my letter. Now we all just wait for what happens next on these meetings. Susan400
thanks for posting this - the link to the two meetings on the committee calendar is
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/ucm247236.htm
an email address is given for Paul Tran and presumably that is a valid way to submit written comments. At this point anything but approval seems unlikely however this is a good (and rare) opportunity to remind the powers that be that approval will still exclude a lot of hcv patients . Both tela/boce depend on a significant ifn response for success. Odds for non-responders are in the 30s. For those for whom time is running out, the FDA could open access to multi-DAA combos already in phase IIb/III testing. This was the objective of the initiative they sponsored last year, which, as best I can tell, has gone nowhere.
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/ucm247236.htm
an email address is given for Paul Tran and presumably that is a valid way to submit written comments. At this point anything but approval seems unlikely however this is a good (and rare) opportunity to remind the powers that be that approval will still exclude a lot of hcv patients . Both tela/boce depend on a significant ifn response for success. Odds for non-responders are in the 30s. For those for whom time is running out, the FDA could open access to multi-DAA combos already in phase IIb/III testing. This was the objective of the initiative they sponsored last year, which, as best I can tell, has gone nowhere.
I hope that there's enough equal support on the Boceprevir side of these meetings and that it's not all in the Telaprevir bucket. I would like to see both of them approved. There are some of us who will not be taking the Telaprevir no matter what (me), even if Boceprevir for some reason is not approved. I think that for those people who need a shorter treatment and don't mind, or don't get a rash..., go for the Telaprevir..., but for the other people (me), we need to have another option, i.e. Boceprevir. It doesn't matter to me if I end up needing to do 48 wks, if I even respond to it. However, it matters alot to me if I look like a pepperoni pizza with the hives that I got when I was exposed to the Telaprevir and if I have to deal with the itching that went along with those hives.., that matters alot to me as well. So, I'm hoping that they both get approved, for each group of people. Susan400
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