Oslo, Norway, 11 September 2003
The Dermatologic and Ophthalmic Drugs Advisory Committee to the US Food and Drug Administration (FDA), met yesterday in Washington to review PhotoCure's NDA for Metvix® (methyl aminolevulinate) for the treatment of skin cancer (Basal Cell Carcinoma (BCC)).
The committee considered questions posed by the FDA based on data presented by both the FDA and PhotoCure ASA. After a long deliberation the committee reached the conclusion that it could not at present recommend Metvix® for approval for the treatment of primary nodular BCC. The decision was reached on a nine to three vote and was based on the efficacy results in the clinical studies submitted in the new drug application (NDA). However, members of the committee pointed out there was a medical need for Metvix® in certain patient populations with BCC and there will be further discussions with the FDA on this.
There were no safety concerns relating to Metvix® therapy and the committee voted unanimously in support of this issue.
A final decision on PhotoCure's NDA for Metvix® for the treatment of BCC is expected once the FDA has further evaluated the non-binding recommendations of the advisory committee.
PhotoCure's President and CEO, Professor Vidar Hansson, who was present at the committee meeting, commented: "We are disappointed that the advisory committee did not recommended the approval of Metvix® for the treatment of primary nodular BCC at this stage. Further discussions on alternative BCC indications for Metvix® are expected to be held with the FDA shortly. However we are happy that there were no safety issues, which we expect will lead to the FDA granting final approval for Metvix® for treatment of actinic keratosis."
PhotoCure's first NDA for Metvix® (methyl aminolevulinate) in the US, for the treatment of the pre-malignant skin disorder (actinic keratosis), was deemed approvable by the FDA in September 2002. As a result of today's meeting, which raised no safety issues relating to the use of Metvix® therapy, PhotoCure is confident of receiving final approval for the use of Metvix® for this indication in due course.