Biofrontera files sNDA for Ameluz-PDT in treatment of sBCC

Biofrontera (BFRI) announced the submission of an sNDA to the FDA, seeking approval of Ameluz-PDT for the treatment of sBCC. The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera’s U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz label to include treatment of sBCC treatment with PDT using its BF-RhodoLED or RhodoLED XL red light lamps. The double-blind, randomized, placebo-controlled, multi-center Phase 3 study evaluated the safety and efficacy of Ameluz-PDT in 187 patients with one or more clinically and histologically confirmed superficial BCCs. Participants received one cycle of two PDT treatments 1-2 weeks apart. If required, a second treatment cycle was repeated at three months. The study’s primary endpoint was a composite measure of complete clinical and histological clearance of one preselected “main target lesion” at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz-PDT arm compared to 4.8% in the placebo-PDT arm, a highly significant statistical difference. Key secondary endpoints demonstrated even higher efficacy with complete histological clearance of the MTL seen in 75.9% of patients with Ameluz compared to 19.0% with placebo, complete clinical clearance of the MTL achieved in 83.4% of patients treated with Ameluz compared to 21.4% with placebo, and total clearance of all sBCC lesions in 64.1% of subjects treated with Ameluz compared to 4.8% with placebo.