The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Biofrontera Inc.'s Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, permitting an increased dosage for the treatment of actinic keratosis (AK) on the face and scalp. The approval allows for the use of up to three tubes of Ameluz per treatment, a significant increase from the previous limit of one tube, offering greater flexibility in treating larger or multiple affected areas.
The sNDA was supported by data from two Phase 1 safety studies involving 116 patients. These studies demonstrated that the increased dosage did not elevate the blood concentration of the active ingredient to levels known to cause adverse effects. The systemic and application site adverse events observed with the triple-tube dosage were comparable to those seen with the single-tube dosage, reinforcing the safety profile of the expanded use.
Clinical Significance
Actinic keratosis affects approximately 58 million people in the U.S., with around 13 million treatments performed annually. Untreated AK lesions can progress into squamous cell carcinoma, a potentially life-threatening skin cancer. The ability to treat the entire affected field is crucial in preventing this progression. According to Dr. Jonathan Weiss, investigator and co-managing partner at Georgia Dermatology Partners, up to 60% of squamous cell carcinomas originate from untreated AK lesions.
Biofrontera's Perspective
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed satisfaction with the FDA's decision, noting that efforts are underway to secure reimbursement for the updated labeling. The approval is expected to enhance the convenience of treatment for healthcare providers and patients, allowing dermatologists to offer a more comprehensive treatment option while maintaining the proven efficacy and safety profile of Ameluz.
Implications for Treatment
Ameluz is recognized by the FDA for both lesion-directed and field-directed treatment of AKs. The increased dosage provides healthcare professionals with the flexibility to treat larger areas, aligning with the growing emphasis on preventive dermatology. This expanded use not only enhances the effectiveness of AK management but also improves patient outcomes in skin cancer prevention.
Ongoing and Future Developments
Biofrontera is also conducting clinical trials to explore the use of Ameluz in treating other dermatological conditions, including superficial basal cell carcinoma, moderate-to-severe acne, and peripheral AK. Data from these trials are expected between late 2024 and the second half of 2025.
