Oslo, Norway, 3 December 2004
The US Food and Drug Administration (FDA) has reviewed PhotoCure's amendment, submitted in June 2004, to the marketing application (NDA) for Metvix® (methyl aminolevulinate) for the treatment of skin cancer (Basal Cell Carcinoma). FDA concludes that the current data submitted was insufficient for approval of the proposed indication.
PhotoCure is now evaluating the requirements set out by FDA. These requirements include further clincal phase III studies and may take up to 2 years. The alternatives will be discussed with FDA.
The FDA has previously reviewed Metvix for treatment of pre cancerous skin lesions (Actinic Keratosis), where an approval was obtained in July 2004. The approved trade name for Metvix in the United States is Metvixia(TM).