Biofrontera, the specialist for the treatment of sun-induced skin cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of its combination topical prescription drug Ameluz® (BF-200 ALA) and medical device BF-RhodoLED® for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp. The approval covers lesion-directed as well as field-directed treatment and follows thorough review of the Company’s New Drug Application (NDA), which was submitted in July 2015.
This marks an outstanding accomplishment for a start-up company that is rarely seen in European companies of comparable size. It is the fourth marketing approval of Ameluz® worldwide and further validates the comprehensive safety and efficacy data from the Company’s three pivotal multi-center clinical trials, which were conducted in the European Union (EU) and collectively evaluated 779 patients with four to eight mild to moderate AK lesions.
The compelling results obtained from these studies demonstrate a complete patient response rate of 91% when Ameluz® was paired with BF-RhodoLED® PDT lamp. Additionally, Ameluz® has exhibited positive long-term effects with low recurrence over the course of 12 months, and in a pivotal phase III trial performed on entire treatment fields it demonstrated long-lasting skin rejuvenation effects in sun-damaged skin regions. Ameluz® is the first PDT drug with field-directed treatment covered in the label.
Ameluz® was granted marketing authorization by the European Medicines Agency (EMA) in December 2011 for the treatment of mild and moderate AK on the face and scalp. The indication was extended to include field cancerization in 2016, and also in 2016 the EMA provided a positive opinion on Biofrontera’s application for indication expansion to superficial and nodular Basal Cell Carcinoma. BF-RhodoLED® was approved as a medical device in the EU in November 2012.