FDA Approves New Combo Drug Plus Device Treatment for AKs

The FDA approved Biofrontera AG’s 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 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 results from these studies demonstrate that Ameluz is significantly superior to the standard of care, with a complete patient response rate of 91 percent when paired with BF-RhodoLEDPDT 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 but asymptomatic skin regions.

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. BF-RhodoLED was approved as a medical device in the EU in November 2012.

Ameluz in combination with BF-RhodoLED light treatment is an innovative alternative to existing PDT for AK, which is characterized by lesions caused by frequent and prolonged exposure to the sun’s ultraviolet rays. Typically, AK lesions occur on the face, scalp, lips, arms, and hands, often resulting in the formation of rough, scaly and discolored skin patches. AK affects more than 58 million people in the US alone, which, if left untreated can develop into squamous cell carcinoma (SCC), a potentially fatal skin disease with rapidly growing incidence. According to S3-guidelines, the highest level of treatment guidelines, multiple AKs should be treated in a field-directed approach, and Ameluz is the first PDT drug with field-directed treatment covered in the label.

Biofrontera expects commercial launch of Ameluz and BF-RhodoLED in the US by September 2016. The company established a US subsidiary in 2015 to build the infrastructure necessary to commence US operations and initiate sales and marketing activities. The company is currently hiring personnel in preparation for the product launch.

“We are extremely pleased with the FDA’s decision to approve Ameluz and BF-RhodoLEDfor the treatment of actinic keratosis. We expect early adoption from dermatologists as we showcase the response rates of guideline compatible field treatment, which is not covered by the label of competing technology,” commented Prof. Dr. Hermann Luebbert, CEO of Biofrontera. “The US represents a large and growing market opportunity for the company and we have been eagerly preparing for the US launch of Ameluz. We are excited about our growth prospects in the US, Europe, and other regions around the world and we look forward to expanding the indication for Ameluz to basal cell carcinoma first in the EU, followed by the US”