Oslo, Norway, 23 September 2002
In September 2001 PhotoCure ASA filed a new drug application (NDA) with the Food and Drug Administration (FDA) in the US for Metvix® PDT for treatment of pre-malignant skin changes or Actinic Keratosis. PhotoCure ASA has now received a letter from the FDA stating that the review of the NDA is completed and that the application is approvable.
As PhotoCure expected, certain items have to be resolved with the FDA before a final marketing approval can be granted. These items are mostly related to completion of the Metvix® PDT labelling and written information to health care personnel and patients. In addition, PhotoCure has to commit itself to perform limited phase IV clinical studies after final marketing approval.
President and CEO of PhotoCure ASA, professor Vidar Hansson, says: “We are extremely pleased to receive this approvable letter from the FDA only 12 months after our filing of the marketing authorisation application (NDA) in the US. This is the most important milestone for PhotoCure since PhotoCure was founded. The US market represents between 50-60 % of the global pharmaceutical market and we plan to follow up this with a NDA for Metvix® PDT for treatment of skin cancer or basal cell carcinoma later this year.”