
[Federal Register: April 26, 2011 (Volume 76, Number 80)]
[Notices]               
[Page 23324-23325]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap11-62]                         

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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: EDMAC@fda.hhs.gov, 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]
BILLING CODE 4160-01-P

