 The
Food and Drug Administration (FDA) will hold a public meeting
of its Endocrinologic and Metabolic Drugs Advisory Committee to
discuss the safety and efficacy of new drug application (NDA)
22-505, Egrifta (tesamorelin acetate), sterile lyophilized powder
for injection, by Theratechnologies, Inc. Egrifta is an analogue
(a chemical compound that resembles another compound in structure)
of growth hormone releasing hormone (GHRH). The proposed indication
(use) for Egrifta in this application is to induce and maintain
a reduction of excess visceral abdominal fat in human immunodeficiency
virus (HIV)-infected patients with lipodystrophy (a condition
in which abnormal deposits of fat are seen partly as a result
of using certain drugs to treat HIV disease).
The meeting will take place on May 27, 2010, from 8 a.m. to 5
p.m, at The
Inn and Conference Center, University of Maryland University
College (UMUC), 3501 University Blvd. East, Adelphi, MD. You can
contact the hotel directly at 301-985-7300 for directions or to
arrange accommodations.
The meeting will be open to the public, and no registration is
required.
Interested persons may present data, information, or views, orally
or in writing, on issues pending before the committee.
Written submissions may be made to Paul Tran, 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, FAX: 301-827-6776, e-mail:
paul.tran@fda.hhs.gov
on or before May 13, 2010.
Oral presentations from the public (the open public hearing) will
be scheduled between approximately 1 p.m. and 2 p.m. 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 May 5, 2010.
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.
Those requesting time to present will be notified regarding their
request to speak by May 6, 2010.
FDA intends to make background material available to the public
no later than 2 business days before the meeting. 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.
Background material can be found at www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee
link.
Please call the FDA Advisory Committee Information Line for up-to-date
information about this meeting, at 1-800-741-8138 (301-443-0572
in the Washington, DC area), and use code 3014512536. A notice
in the Federal Register about last minute modifications that impact
a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore,
you should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
4/2/10
Source
R
Klein and K Struble (U.S. Food and Drug Administration). FDA Advisory
Committee Meeting to Review Egrifta. Media announcement. March
22, 2010.
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