|CDER||May 19, 2011
||8:00 a.m. to 5:00 p.m.||Hilton Hotel
8727 Colesville Road
Silver Spring, Maryland
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 “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 the complete 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.
- 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 1:00 p.m. to 2:00 p.m., on May 19, 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 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.
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.
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.
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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2)