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Biofrontera Inc, a US-based biopharmaceutical company specialized in the commercialization and development of photodynamic therapy (PDT), announced that the US Food and Drug Administration (FDA) has completed its filing review and accepted filing of the company’s supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED red-light lamp series for the treatment of superficial basal cell carcinoma.
The US Food and Drug Administration has identified no filing deficiencies and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 28, 2026.
If approved, this new indication would represent a significant clinical expansion of the Ameluz photodynamic therapy platform beyond its existing US Food and Drug Administration approval for treatment of actinic keratosis. It would also further validate Biofrontera’s photodynamic therapy approach, which combines Ameluz’s nanoemulsion technology with red-light illumination designed to penetrate deeper into tissue compared with shorter wavelengths of light such as green and blue, enabling treatment of lesions extending into deeper skin layers.
Basal cell carcinoma is the most common cancer in the United States, with approximately 3.6 million cases diagnosed annually, and published estimates suggest that 10–25 per cent of these cases are of the superficial subtype. Current treatment options often rely on surgical destructive approaches, which may not be appropriate or preferred for all patients.
“We are proud of the investments we continue to make in this specialty. This milestone represents an important step forward in our strategy to expand the clinical utility of Ameluz and reinforce photodynamic therapy as a versatile platform in dermatology,” said Dr. Hermann Luebbert, chief executive officer of Biofrontera. “The US Food and Drug Administration’s acknowledgement of no filing deficiencies in our supplemental New Drug Application reflects the strength of the data package and allows us to move forward with confidence toward a potential new indication that addresses a meaningful unmet medical need.”
If approved, Ameluz photodynamic therapy for the treatment of superficial basal cell carcinoma would offer dermatology providers and their patients a non-invasive treatment option aligned with real-world practice needs. Biofrontera believes this indication has the potential to meaningfully expand the addressable market for Ameluz and strengthen the company’s position in medical dermatology.
If approved, Ameluz would be the first and only photodynamic therapy photosensitizer indicated for the treatment of superficial basal cell carcinoma (sBCC) in the United States. Basal cell carcinoma is the most common skin cancer in the US with 3.6 million cases diagnosed annually.
Biofrontera commercializes the drug-device combination Ameluz with the RhodoLED lamp series for photodynamic therapy of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers. The company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne.
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