[Federal Register Volume 76, Number 80 (Tuesday, April 26, 2011)]
[Notices]
[Pages 23324-23325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10003]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Endocrinologic and Metabolic 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 19, 2011, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910. The hotel telephone number is
301-589-5200.
Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm.
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX 301-847-8533, e-
mail: [email protected], or FDA Advisory
[[Page 23325]]
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. 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.
Agenda: On May 19, 2011, the committee will discuss the findings of
the Action to Control Cardiovascular Risk in Diabetes-Lipid (ACCORD
Lipid) trial as they relate to the efficacy and safety of the approved
new drug application (NDA) 22224, TRILIPIX (fenofibric acid) delayed
release capsules, manufactured by Abbott Laboratories.
TRILIPIX (fenofibric acid), an active form of fenofibrate, is
indicated for use in combination with a 3-hydroxy-3-methyl-glutaryl-
coenzyme A reductase inhibitor, commonly referred to as a ``statin'',
to lower high levels of serum triglycerides and raise low levels of
high-density lipoprotein cholesterol in patients with mixed
dyslipidemia and coronary heart disease (CHD) or CHD risk equivalent
who are on optimal statin therapy to achieve their low-density
lipoprotein cholesterol goal.
The ACCORD Lipid study was a randomized, double-blind, placebo-
controlled add-on trial, which is the kind of clinical trial designed
to provide data with strong measures of accuracy and reliability. The
ACCORD Lipid study evaluated the efficacy and safety of adding
fenofibrate therapy to treatment with the statin, simvastatin in
subjects with type 2 diabetes mellitus. The results of the ACCORD Lipid
trial indicated that there was no statistically significant difference
in the proportion of clinical trial subjects treated with simvastatin
plus placebo verus simvastatin plus fenofibrate who experienced a major
adverse cardiac event. In a prespecified subgroup analysis from the
ACCORD Lipid trial, there was an increase in the proportion of female
trial subjects treated with simvastatin plus fenofibrate versus
simvastatin plus placebo who experienced a major adverse cardiac event.
The clinical significance of this finding is unclear.
An additional safety concern associated with the use of fenofibrate
plus simvastatin, or any other statin, is muscle toxicity.
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 is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
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 on or before May
12, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person 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, 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 May 6, 2011.
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 Paul Tran at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10003 Filed 4-25-11; 8:45 am]
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