PhotoCure - Progress in FDA's evaluation of Metvix® application
Oslo, Norway, 8 August 2003
PhotoCure ASA has previously reported the filing of two New Drug Applications for Metvix® (methyl aminolevulinate) with the US Food and Drug Administration (FDA). The first application, regarding the treatment of premalignant skin disorders (actinic keratosis), is already deemed approvable by the FDA. A second application was filed earlier this year with the aim of expanding the indications for Metvix® to include skin cancer (basal cell carcinoma).
PhotoCure has been informed by the FDA that an advisory committee meeting will be held on 10 September 2003. At this meeting, PhotoCure's application for skin cancer will be presented to FDA's Dermatologic and Ophthalmic Drugs Advisory Committee, which in turn, will give its recommendations to the FDA.