|CDER||June 10, 2015||8:00 a.m. to 5:00 p.m.||Hilton Washington DC North/Gaithersburg|
The Grand Ballroom
620 Perry Parkway
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.
Public Participation Information
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. on June 10, 2015. 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, 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.
CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the Endocrinologic and Metabolic Drugs Advisory Committee meeting.
- Philip Bautista, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)- 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 FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
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 (301) 796-9001 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 Public Conduct During FDA Advisory Committee Meetings 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).