Biofrontera files NDA at FDA for Ameluz + BF-RhodoLED device to treat actinic keratosis

Biofrontera AG, a biopharmaceutical company focusing on sun-induced skin cancer, has submitted a New Drug Application (NDA) to the FDA for its combination prescription drug Ameluz and medical device BF-RhodoLED. The combination of both products could be applied in photodynamic therapy.

Unlike the US which requires combination approval, Ameluz and BF-RhodoLED were listed under separate filings in the EU. Ameluz was granted marketing authorization by the European Medicines Agency (EMA) in December 2011 for the treatment of mild and moderate actinic keratosis on the face and scalp. Biofrontera’s PDT lamp BFRhodoLED was approved as a medical device in the EU. The FDA combination drug and device application is extremely complex and required additional phase III testing prior to submission.

The phase III actinic keratosis field therapy study with the drug/light combination reported complete clearance in over 90% of treated patients, along with a strong skin rejuvenation effect. The filing also includes results from two additional Phase III studies as well as results from two drug safety studies requested by the FDA. The comprehensive dossier was submitted to FDA on 10 July 2015. Biofrontera has been in close dialogue with FDA since July 2012 in order to prepare the NDA in coordination with the authority.