• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Advisory Committees

  • Print
  • Share
  • E-mail

November 2, 2011: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

 

Center Date Time Location
CDER November 2, 2011
 
8:00 a.m. to 5:00 p.m. Hilton Washington DC/Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland

Agenda

On November 2, 2011, the committee will discuss supplemental new drug applications 21-687 and 21-445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering-Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3-methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipids in the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.

Meeting Materials

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:

 

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 October 19, 2011.
  • Oral presentations from the public will be scheduled between approximately 1 p.m. – 2 p.m., November 2, 2011. Those desiring to make 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 October 11, 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 October 12, 2011.

Webcast Information

CDER will not be providing a webcast of the Endocrinologic and Metabolic Drugs Advisory Committee meeting.

Contact Information

  • Paul Tran, R.Ph.
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, MD 20993
    Phone: 301-796-9001
    Fax: 301-847-8533
    E-mail: EMDAC@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138
    (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 Website and call the appropriate advisory committee hot line/phone 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 Paul Tran 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).