FDA approves Ameluz along with combination device for actinic keratosis

The US Food and Drug Administration (FDA) has approved 5-aminolevulinic acid (ALA; Ameluz, Biofrontera) gel in combination with the activating BF-RhodoLED photodynamic therapy (PDT) lamp for treatment of patients with actinic keratosis (AK). The approval is for lesion-directed as well as field-directed treatment.

Dr Hermann Luebbert, chief executive of Biofrontera, said the company hopes to expand the drug’s indication to basal cell carcinoma in the European Union (EU) and then the United States. The FDA approval follows discussion of three pivotal multi-centre clinical trials of the combination treatment in patients with mild-to-moderate AK on the face and scalp in the EU.

The studies collectively evaluated the treatment in 779 patients with four to eight mild-to-moderate AK lesions. The studies showed a complete patient response rate of 91% when the gel was combined with the BF-RhodoLED PDT lamp, according to the company. The treatment was effective long-term and recurrence was low during the 12-month course. In addition, the treatment showed “long-lasting skin rejuvenation effects in sun-damaged but asymptomatic skin regions.”