FDA Advisory Meetings: Adefovir, Nov. 1; Resistance Testing Nov. 2-3
Two meetings of the FDA Antiviral Drugs Advisory Committee will take place in early November, in Gaithersburg, Maryland, near Washington DC. (Public transportation is available; take the Metro to the Shady Grove stop--the end of the Red Line--and call the hotel or take a taxi to the Gaithersburg Holiday Inn.) These meetings are open to the public, with one hour of each meeting scheduled for public testimony.FDA advisory committee meetings are usually the place where it is possible to learn the most about new drugs or tests. The adefovir meeting will probably determine whether Gilead Sciences' drug adefovir dipivoxil will be approved (the FDA is not required to follow an advisory committee recommendation, but almost always does). Community sentiment has been mixed on this drug, due to the difficult balance of risks and benefits; we are seeing some support for approval but with a narrow indication.
Note that the other meeting, on genotypic and phenotypic resistance testing, will focus on their use in antiretroviral drug development, but will also look at evidence supporting clinical use.
Here is an October 12 FDA announcement of these meetings:
November 1999 Meetings ANTIVIRAL DRUGS ADVISORY COMMITTEE
On November 1, 1999, from 8:30 a.m. to 5 p.m. the committee will discuss new drug application (NDA) 20-993, adefovir dipivoxil (Gilead Sciences Incorporated), for the treatment of HIV (human immunodeficiency virus) infection. The meeting will be held in The Ballrooms at the Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland. If you need accommodations or directions to the hotel, the Holiday Inn can be reached directly at 301-948-8900. The open public hearing portion of the meeting will be scheduled between approximately 1 p.m. and 2 p.m. Interested persons may present data, information or views, orally or in writing, pertinent to the issues under discussion by the committee (see below for more information on presentations).
On November 2 and 3, 1999, from 8:30 a.m. to 5 p.m., the meeting will be dedicated to presentations and committee discussions to address issues related to testing for development of resistant Human Immunodeficiency Virus (HIV-1), with an emphasis on its potential role in antiretroviral drug development. The primary objectives of these deliberations are to obtain advisory committee recommendations on the amount and type of resistance data needed to support both preclinical and clinical development of antiretroviral drugs and antiretroviral product labeling. This two-day meeting will explore the following scientific issues: performance characteristics of genotypic and phenotypic assays; definitions of antiviral drug resistance; relationships between the development of mutations or reduced susceptibility and treatment outcome; and available evidence supporting the clinical utility of testing for the development of antiviral drug resistance. The open public hearing is scheduled for November 3, 1999, from 1 - 2:00 p.m. Those wishing to make a formal presentation during the open public hearing at either of these meetings should notify Rhonda Stover or John Schupp, Center for Drug Evaluation and Research, HFD-21, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857, 301-827-7001. Please submit a brief statement of the general nature of the evidence or arguments to be presented, along with the names and affiliation of proposed speakers, and an indication of the approximate time requested for the presentation. Time allotted for each presentation may be limited depending on the number of requests received.
For up-to-date information about these meetings, or other meetings of the Antiviral Drugs Advisory Committee, please call the FDA Advisory Committee Information Line at 1-800-741-8138 (301-443-0572 in the Washington, D.C. area) and enter code no. 12531.
