PhotoCure - Metvix® application USA
PhotoCure ASA announced today the submission of its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Metvix® cream in combination with the CureLight lamp in PDT (photodynamic therapy) for the treatment of actinic keratosis (AK, pre-cancerous skin lesions). Treatment consists of Metvix® cream application to the AK lesions for three hours, followed by illumination with red light.
Results show that Metvix® PDT was significantly more effective than placebo with respect to the proportion of patients showing complete lesion response and complete patient response at three months after treatment.
Metvix® PDT was also compared to cryotherapy, which is a current standard therapy for AK, and found to give a better therapeutic outcome than cryotherapy. Metvix® PDT gave a superior cosmetic outcome (in particular, there was less hypopigmentation with Metvix® PDT than with cryotherapy, 5% vs. 29%).
Metvix® PDT is associated with mainly mild and transient, local phototoxicity reactions, and there was no evidence of systemic adverse reactions, and no serious adverse events related to the treatment.
The results from the clinical programme confirm that Metvix® PDT is a safe and efficacious new drug for the treatment of actinic keratoses. Multiple lesions can be successfully treated in one treatment session. Cosmetic outcome is outstanding. This is particularly important, as AK lesions are often located on the face and scalp. The short application time before illumination (three hours) as well as the great patient tolerance of treatment contributes to making treatment with Metvix® PDT convenient for both patients and health care providers.
Professor Vidar Hansson, PhotoCure's CEO and President, commented, "Metvix® PDT is now a step closer to commercialisation in the worlds largest market, where, subject to the FDA's approval, it will offer safe and effective treatment with outstanding cosmetic results to a large number of patients". He added, "We are very pleased to be able to submit this NDA, which is the first in PhotoCure's history. It represents an extraordinary achievement by the PhotoCure team. We have made great progress with Metvix® PDT in 2001, having received approval in Sweden, as well as submitting registration applications to 19 countries; 16 in Europe, as well as to Australia, New Zealand and now to the US."
Metvix® PDT is an innovative treatment for pre-malignant skin lesions and skin cancer that combines the local application of Metvix® cream to the skin, which is then absorbed into pre-malignant or malignant cells. The drug is activated through illumination using a proprietary red light source called CureLight. Metvix® PDT kills the pre-malignant or malignant cells selectively and leaves the normal skin intact, thereby healing the skin without causing scars or blemishes.
AK, also known as 'sun spots', is the most commonly diagnosed pre-malignant skin condition. Worldwide, more than 20 million cases of AK occur each year. Early and effective treatment of AK is important as if it is left untreated a certain number of these lesions may progress to squamous cell carcinoma, an aggressive and potentially life-threatening type of skin cancer.