New NDA for Metvix® PDT Submitted to FDA
Oslo, Norway, 18 February 2003 Today PhotoCure announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Metvix® PDT (photodynamic therapy) for the treatment of nodular and superficial basal cell carcinoma (BCC, skin cancer). PhotoCure ASA recently obtained an approvable letter from the US FDA for actinic keratosis (AK), pre-malignant skin lesions. The NDA comprises data from six pivotal clinical studies, in which Metvix® PDT was used to treat 340 patients with a total of 498 BCC lesions. Metvix® PDT was compared to surgery and