Public FDA hearing on October 17th and 18th

No Comments
FDA Advisory Committee Information:

Notices of the upcoming Endocrinologic and Metabolic Drugs Advisory Committee meetings have been made available on the FDA website: http://www.fda.gov/advisorycommittees/default.htm

Date and Time: The meetings will be held on October 17 and 18, 2012, from 8 a.m. to 5 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

Please note that visitors to the White Oak Campus must enter through Building 1.

Agenda: On October 17, 2012, the committee will discuss new drug application (NDA) 203858, lomitapide capsules, by Aegerion Pharmaceuticals, Inc. The proposed indication (use) is as an adjunct to a low-fat diet and other lipid-lowering drugs with or without low-density lipoprotein (LDL) apheresis to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and triglycerides in patients with homozygous familial hypercholesterolemia. (Apheresis is a laboratory technology used to remove LDL from the bloodstream.)

On October 18, 2012, the committee will discuss new drug application (NDA) 203568, mipomersen injection, by Genzyme Corporation. The proposed indication (use) is as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce low-density lipoprotein (LDL) cholesterol, apolipoprotein B, total cholesterol, non-high density lipoprotein-cholesterol and lipoprotein (a) in patients with homozygous familial hypercholesterolemia.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

If you are unable to attend either meeting but wish to express your views about the need for more treatment options, written submissions may be made to the contact person (see below) on or before October 2, 2012.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on October 17 and October 18, 2012. 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 September 24, 2012. 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 September 25, 2012.

Contact Person:
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.

Leave a Reply