Biofrontera says FDA approves use of up to 3 tubes of Ameluz topical gel 10%

Biofrontera announced that the U.S. FDA has approved the company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz per treatment. This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients, Biofrontera said in a statement. “We are delighted with the FDA’s decision to approve the use of up to three tubes of Ameluz per treatment,” stated Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “We are now working with Medicare and commercial payers to obtain reimbursement for this label update and will notify our customers accordingly.” The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz.