Fast-Tracking the First AIDS Drug
The drug zidovudine, brand name Retrovir (formerly called azidothymidine or AZT), was originally developed in 1964 as a potential cancer treatment, but it showed little promise for this use. Years later, a fresh look at the compound's anti-viral properties led to its becoming the first drug approved to treat AIDS--acquired immune deficiency syndrome.
Close cooperation between FDA and the drug's sponsors, Burroughs Wellcome Co. of Research Triangle Park, N.C., and the National Cancer Institute, helped to expedite the testing and review of zidovudine. FDA approved the drug to treat certain patients with AIDS on March 20, 1987--within just four months of receiving a new drug application from Burroughs Wellcome.
FDA press officer Brad Stone interviewed Dr. Ellen Cooper, group leader (anti-virals) of FDA's Division of Anti-Infective Drug Products, and Dr. James Bilstad, deputy director (medical affairs) of FDA's Office of Biologics Research and Review, to trace the development and approval of this important new drug.
FDA CONSUMER: Zidovudine is categorized as an anti-viral drug. What is an anti-viral drug, and how does it work in treating AIDS?
COOPER: An anti-viral drug interferes with viral replication. Zidovudine works in part by inhibiting reverse transcriptase, an enzyme necessary for the replication of HIV [human immunodeficiency virus], the retrovirus that causes AIDS. In addition, the virus is "tricked' into incorporating zidovudine into its DNA replication chain. This action effectively aborts the virus's ability to replicate itself.
FDA CONSUMER: How does zidovudine trick the virus?
COOPER: Zidovudine's chemical structure is in some ways very similar to thymidine --one of the key nucleosides, or links, that make up the DNA genetic chain that reproduces the AIDS …