First Approval Of 3M's Genital Wart Product

10 March 1997

3M Pharmaceuticals has been granted approval in the USA for Aldara(imiquimod), a topical treatment for genital and perianal warts. The USA is the first country to approve the drug, which is the first new treatment for genital warts in five years. It should be launched in June, and pricing has not yet been established.

Imiquimod is a biological response modifier, and induces the production of cytokines, particularly interferon alpha and interleukins such as IL-12, from immune cells, according to Dick Miller, one of the co-discoverers of the compound. It is the first agent in 3M's BRM series to reach this stage of development.

In a 209-patient trial, 50% (72% of females, 33% of males) had wart clearance with imiquimod after 16 weeks compared to 11% on placebo. Of those who cleared, 72% (n=39/54) in the imiquimod group and 82% (n=9/11) on placebo remained wart-clear after 12 weeks of follow-up.

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