FDA Botanical Review Team Clears Green Tea-Based Drug As First Approval
This article was originally published in The Tan Sheet
Executive Summary
FDA's Botanical Review Team on Oct. 31 approved its first botanical drug, MediGene's Polyphenon E ointment
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FDA's Botanical Review Team on Oct. 31 approved its first botanical drug, MediGene's Polyphenon E ointment. The active substance in Polyphenon E - an extract from green tea leaves with a defined catechin composition - treats external and perianal genital warts, according to Germany-based MediGene's announcement. Polyphenon E is the first NDA the Botanical Review Team has approved. The team completed the guidance for botanical drugs in 2004 (1 (Also see "FDA Botanical Drug Products Final Guidance Stresses Batch Consistency" - Pink Sheet, 14 Jun, 2004.) p. 12). No other company has made its IND public at this time. Bradley Pharmaceuticals will market Polyphenon E in the U.S. Fairfield, N.J.-based Bradley, which expects to launch the product during the second half of 2007, agreed to pay MediGene $14 mil. upon the product's approval, according to the release. MediGene said it expects annual U.S. sales for the drug to be up to $100 mil. A spokesperson for MediGene said the Botanical Review Team was involved throughout the New Drug Application process for Polyphenon E. The company said FDA's Division of Dermatologic & Dental Products performed the review. "Meetings and teleconferences with the sponsor regarding the quality and control of the green tea extract were conducted with the chemistry reviewers and representatives of the Botanical Review Team," the company added. The company said it plans to submit Marketing Authorization Applications for the drug in Europe before the end of the year. Between 1982 and June 2006, FDA received 286 Investigational New Drug Applications for botanical drugs, according to Shaw Chen, MD, PhD, Associate Director of CDER's Office of Drug Evaluation I (2 (Also see "Botanical Drug Sponsors Would Benefit From Simpler Indications – FDAer" - Pink Sheet, 14 Aug, 2006.), p. 8). Chen suggested sponsoring botanical drug products with indications for less complex diseases - especially those currently without effective treatment - could speed up FDA's review of new botanical drugs. - Rebekah Moan |