Preliminary regulatory assessment obtained for Metvix® photodynamic therapy for treatment of actinic keratosis

PhotoCure ASA submitted its first marketing authorisation application for Metvix® photodynamic therapy (PDT) for the treatment of actinic keratosis (AK) to the Swedish regulatory authorities (MPA) in May of this year. As part of the overall review process, the MPA has now given its initial response to the file provided by PhotoCure in its marketing application. As is normal, the MPA has asked PhotoCure to clarify certain points which have been raised during its review of the Metvix® PDT documentation.

Vidar Hansson, President and CEO, commenting on the response from the MPA said: “The authorities have taken slightly longer than they originally expected to provide us with their initial feedback. However, we are happy that we have received the first written response, and that we are now able to continue the work needed to finalise our application in order to gain marketing authorisation for Metvix® PDT. We believe we can answer the MPA’s initial questions appropriately and keep the approval process on track.”