Polyphenon E Ointment

Generic name: green tea polyphenol extract
Drug classes: Anorectal preparations, Topical anti-infectives
Approval date: October 31, 2006
Company: MediGene AG

Treatment for: Genital and Perianal Warts

The U.S. Food and Drug Administration (FDA) has approved Polyphenon E Ointment, 15%, a new drug indicated for the treatment of external genital and perianal warts.

Polyphenon E Ointment contains a concentrate of catechines with a defined composition. These natural substances are extracted from green tea leaves in a specific procedure.

Polyphenon E Ointment is proven effective for the treatment of external genital and perianal warts caused by certain strains of human papilloma virus (HPV).

During clinical development, Polyphenon E Ointment tested in the treatment of genital warts showed high and sustained efficacy with very few adverse events. The results come from an international phase III development program, during which more than 1,000 patients in 15 countries were medicated with Polyphenon E Ointment.

Genital warts are benign but painful and disfiguring skin tumors in the genital and anal areas. The sexually transmitted disease is caused by human papilloma viruses. Approximately 30 million people worldwide are infected by these viruses (HPV type 6 or 11) that cause genital warts. Genital warts are one of the fastest spreading venereal diseases worldwide.

Current treatment for this condition primarily consists of cryosurgery and the topical therapy Aldara (imiquimod).

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