FDA Approves Up To 3 Tubes of Ameluz Topical Gel, 10% In 1 Treatment

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to increase the maximally approved dosage from one to three tubes of Biofrontera Inc.’s Ameluz® per treatment, the company announced.

Biofrontera Inc. said in a press release that the approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for actinic keratosis (AK) on the face and scalp, leading to greater convenience for both healthcare practitioners and their patients.

“We are delighted with the FDA’s decision to approve the use of up to three tubes of Ameluz® per treatment,” Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., said in the release. “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®.

Dr. Luebbert noted that Ameluz® is the only PDT photosensitizer indicated by the FDA for both lesion-directed and field-directed treatment of AKs, and that the approval will allow dermatologists to offer the more comprehensive option they desired for their patients, while maintaining the proven efficacy and safety profile of Ameluz®.

“Up to 60% of squamous cell carcinomas begin as untreated AK lesions, so it’s important for us to be able to treat the entire affected field,” Dr. Jonathan Weiss, investigator and co-managing partner at Georgia Dermatology Partners in Atlanta, said in the press release. “I have used Ameluz® now for more than 7 years for the management of AK because of the demonstrated efficacy and safety it delivers. With the approval of the sNDA, I look forward to being able to use up to three tubes for those patients that need them.”