PhotoCure announces today that the U.S. Food and Drug Administration (FDA) has approved its novel product methyl aminolevulinate, presently called Metvix, for photodynamic treatment of actinic keratosis (sun-induced, pre-cancerous skin condition).
Approval to market the product in the United States is contingent on FDA’s acceptance of a tradename other than Metvix, which is expected in several weeks. The Metvix tradename cannot be used due to similarity of an already existing tradename for another dermatology product.
Metvix works in combination with the CureLight lamp, PhotoCure’s light source used in the clinical trials. As a result of the approval, PhotoCure is entitled to receive a milestone payment of EUR 3 million from Galderma, PhotoCure’s sales and marketing partner outside the Nordic region.
The novel, non-invasive treatment offered by Metvix for pre-cancerous skin conditions combines the local application of cream (Metvix), selectively absorbed into abnormal cells, and illumination with a proprietary red light source (CureLight/Aktilite) to activate the drug.
Professor Vidar Hansson, President and CEO of PhotoCure ASA, commented: “The US approval marks an important milestone in Metvix’s development. Metvix is now approved in 18 European countries, New Zealand and Australia in addition to the US”.