First Approval For Matrix' AccuSite

Matrix has been granted marketing approval for AccuSite (5-fluorouracil and adrenaline) injectable gel in the UK, its first market, for external genital warts. It is also the first product approval for the US-based company.

Matrix has not yet set a date for the product launch and appears to have been somewhat caught on the hop, gaining the UK approval earlier than expected. The company said it will probably launch the product itself later this year in the UK, but will likely seek a marketing partner for other European markets. Previously, Matrix had an agreement with Medeva for the marketing of the product, but this fell through (Marketletter September 25, 1995). In open-label clinical trials, AccuSite was up to 70% effective in clearing genital wart lesions.

License applications have been filed in France, Germany, Italy and Sweden, and Matrix says it also plans to seek decentralized approval in other European Union countries, using the UK as rapporteur.