(BETA) News Briefs: Glaxo Files for Accelerated Approval of 3TC plus AZT


(BETA) News Briefs: Glaxo Files for Accelerated Approval of 3TC plus AZT

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

Glaxo Wellcome submitted an application to FDA in June 1995 for accelerated approval of 3TC in combination with AZT as first-line treatment for HIV infection for adults and children with fewer than 500 CD4 cells/mm3. FDA is now reviewing the data sumbitted by Glaxo Wellcome in the application. An FDA Antiviral Committee meeting set for November 1995 is expected to recommend for or against expedited approval. Final action on the application by FDA may not come until December 1995.

The San Francisco AIDS Foundation is advocating for earlier approval of the 3TC/AZT combination. Earlier approval will likely lead to improved quality of life and longer lifespans for people with HIV and AIDS. See the editorial on page 3 of this issue. See also pages 8-9 of the December 1994 issue of BETA. Glaxo Broadens Access to 3TC

The experimental anti-HIV drug 3TC (lamivudine) has been available for some time outside of clinical studies through an expanded access program. Because of drug supply problems (over 30,000 people worldwide are now receiving the drug through the expanded access program), Glaxo Wellcome in April 1995 limited new, weekly enrollment to 350 people with fewer than 100 CD4 cells/mm3. Fortunately, drug supply has increased in recent months and the company will now accept up to 650 new participants weekly in the program.

In addition, the CD4 requirement has been expanded to include individuals with 300 or fewer CD4/mm3. To enroll patients in the expanded access program, physicians may call 1-800-248-9757. All applications must include a recent lab slip indicating the patient's CD4 cell count. First priority for enrollment in the program will be given to people with fewer than 100 CD4 cells/mm3.


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Always watch for outdated information. This article first appeard in 1995. This material is designed to support, not replace, the relationship that exists between you and your doctor.

Copyright © 1995 - Bulletin of Experimental Treatments for AIDS (BETA). Reproduced with permission. BETA is published four times a year by the San Francisco AIDS Foundation. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. Call 415.487.8060; FAX: 415.487.8069. Mailing Address: P.O. Box 426182, San Francisco, CA 94142-6182.  beta@sfaf.org  http://www.sfaf.org/beta.html

This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1995. AEGIS.