xolair

Posted on: Sat, 04/19/2003 - 12:31am
mmgshih's picture
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Joined: 05/09/2002 - 09:00

I thought I would post this in case anyone is interested in attending the meeting.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 15, 2003, from 8
a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Kimberly Littleton Topper, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12545. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss biologics license application
(BLA) 103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to Human
IgE) by Genentech, Inc., for the treatment of allergic asthma.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by May 8, 2003.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before May 8, 2003, 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.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
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 Kimberly Littleton
Topper at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

Posted on: Thu, 06/19/2003 - 7:42am
Danielle's picture
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Joined: 04/08/2003 - 09:00

Thank you for posting this.

Posted on: Mon, 08/04/2003 - 1:35am
docd3122's picture
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Joined: 01/16/2001 - 09:00

I spoke recently with a Novartis rep regarding Xolair. Novartis has a negotiating division that contracts with your own insurance company to insure coverage. Within the first two weeks of availability, no insurance companies had denied coverage of the product. Phase III trials are supposedly in progress for the peanut/tree nut indication. Many allergists are making sure the patient qualifies for coverage.

Posted on: Mon, 08/04/2003 - 10:27am
MICHELE03142002's picture
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Joined: 03/15/2003 - 09:00

I see you stated that they will begin PHASE III for testing XOLAIR for peanut/tree nut allergy - can you tell me more about this? When are they starting these trials and why would they begin in Stage III and not Stage I? I hope they start soon, since it seems that TANOX could be a lost cause - at least for a while.

Posted on: Tue, 08/05/2003 - 12:17am
Bootsy's picture
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Joined: 11/13/2002 - 09:00

Here is a link regarding Xolair, which has been FDA approved. I haven't had a chance to look extensively through it yet, but thought I would post it.
[url="http://www.xolair.com/index.jsp"]http://www.xolair.com/index.jsp[/url]

Posted on: Tue, 08/05/2003 - 1:38am
docd3122's picture
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Joined: 01/16/2001 - 09:00

My contact at Novartis said that Xolair's trials for the peanut indication were underway. Since efficacy trials have been completed for the other indications, they could jump to phase trialing. Hope this answers your question. If the patient has moderate to severe allergic rhinitis and/or asthma, they could receive this product under that diagnosis.

Posted on: Tue, 08/12/2003 - 2:13am
ajinnj's picture
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Joined: 05/13/2003 - 09:00

The reason the Xolair trials for peanut/ tree nut can start at Phase III instead of Phase I is because Xolair has already been proven "safe". Also I think Xolair was able to use some of the data from the tanox studies. I think Dr. Sampson at Mt. Sinai and probably others are looking for participants (but don't quote me on that).
Allison

Posted on: Tue, 08/12/2003 - 3:35am
esmom's picture
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Joined: 07/25/2001 - 09:00

any idea on getting study infomation and
what the requirements are to be in the
study

Posted on: Tue, 08/12/2003 - 2:23pm
ajinnj's picture
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Joined: 05/13/2003 - 09:00

maybe call the xolair manufacturers directly and ask them if they need participants for the peanut trials and/ or if they could tell you the locations of the study sites as well as the contact person that way you can pick which site is closest to you (if the studies are still open). I don't know if you've ever been involved in any kind of study before but my study is very time consuming so it might be rough on a young kid. I know in my study there is a participant that flies from toronto to new york every 4 weeks for the shots and and the financial componsation is very minimal. i still highly recommend it i just wanted to make you aware of some of the negative sides that you may not have thought of. hope this helps a little. keep us updated if you hear anything
Allison

Posted on: Wed, 08/13/2003 - 12:49am
choguy's picture
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Joined: 02/20/2003 - 09:00

Another suggestion:
You may try these two websites. I did a quick check and nothing came up for "Xolair" or "peanut allergy." That probably means enrollment has not yet begun or the FDA has yet to approve the study (if a protocol was really submitted). The FDA approval of the study protocol can take several months.
Good luck!
Troy
[url="http://www.centerwatch.com"]http://www.centerwatch.com[/url]
[url="http://www.clinicaltrials.gov"]http://www.clinicaltrials.gov[/url]

Posted on: Wed, 05/14/2003 - 10:00am
Corvallis Mom's picture
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Joined: 05/22/2001 - 09:00

Oh dear. This really does sound like the proverbial rock and a hard place, doesn't it?
[url="http://money.cnn.com/2003/05/14/news/companies/xolair.reut/"]http://money.cnn.com/2003/05/14/news/companies/xolair.reut/[/url]

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