Leverkusen, Germany-based Biofrontera said the approval covers its Ameluz drug and BF-RhodoLED medical device for what it calls “photodynamic therapy” to treat mild to moderate actinic keratosis of the face and scalp.
Also known as solar keratosis, actinic keratosis is caused by damage to the skin by the sun’s ultraviolet rays. The Biofrontera treatment uses the Ameluz gel, which contains a photo-activated compound called 5-aminolaevulinic acid. The gel is applied to the keratosis lesions, then exposed after 3 hours to the red light from the BF-RhodoLED lamp, which causes the 5-aminolaevulinic acid to react with oxygen to create a toxic type of oxygen that kills the cancer cells, according to the European Medicines Agency.
Biofrontera won CE Mark approval in the European Union for Ameluz in 2011 and followed up with BF-RhodoLED CE Marking in 2012. The company said it expects to have the combination treatment on the U.S. market by September.
“We are extremely pleased with the FDA’s decision to approve Ameluz and BF-RhodoLED for 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,” CEO Hermann Luebbert said in prepared remarks. “The U.S. represents a large and growing market opportunity for the company and we have been eagerly preparing for the U.S. launch of Ameluz . We are excited about our growth prospects in the U.S., Europe, and other regions around the world and we look forward to expanding the indication for Ameluz to basal cell carcinoma first in the E.U., followed by the U.S.”
Biofrontera said it formed a U.S. subsidiary last year in anticipation of the FDA approval and is hiring ahead of the launch later this year.