[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24262-24263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


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 June 10, 2015, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel phone number is 301-
977-8900.
    Contact Person: Philip Bautista, 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, [email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The committee will discuss the safety and efficacy of 
biologics license application (BLA) 125522, proposed trade name REPATHA 
(established name: Evolocumab) for injection, submitted by Amgen Inc., 
as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-
C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density 
lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-
density lipoprotein cholesterol, triglyceride, and lipoprotein A, and 
to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed 
dyslipidemia, either in combination with a statin or statin with other 
lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination 
with other lipid-lowering therapies in patients who are statin-
intolerant, or alone or in combination with other lipid-lowering 
therapies in patients for whom a statin is not considered clinically 
appropriate. In addition, the committee will discuss the safety and 
efficacy of evolocumab to reduce LDL-C, TC, ApoB, and non-HDL-C, in 
combination with other lipid-lowering therapies (e.g. statins, LDL 
apheresis) in patients at least 12 years of age with homozygous 
familial hypercholesterolemia.
    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 meeting 
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 
27, 2015. Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. to 2:15 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 18,

[[Page 24263]]

2015. 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 19, 2015.
    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 Philip Bautista 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 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10022 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P