Biofrontera (BFRI) has announced that the FDA has approved the company's supplemental New Drug Application (sNDA), allowing for an increase in the maximum approved dosage of Ameluz from one to three tubes per treatment. This approval is backed by two Phase I clinical safety studies, where three tubes of Ameluz were administered to 116 patients. With this approval, the company can now offer larger-field treatment of actinic keratosis on the face and scalp using Ameluz-PDT with the BF-RhodoLED or RhodoLED XL lamp.
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated, "We are actively engaging with Medicare and commercial insurers to secure reimbursement for this label update and will keep our clients informed accordingly."
