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The FDA set its target action date for October, with this sNDA being supported by two phase 1 safety studies on AK patients.
An announcement was released by Biofrontera Inc., a biopharmaceutical company specializing in dermatologic products, that the US Food and Drug Administration (FDA) issued a letter stating no filing review issues were found for the supplementary New Drug Application (sNDA) submitted.1
This new sNDA was submitted to the agency with the aim of raising the maximum dosage of aminolevulinic acid hydrochloride (Ameluz) from a single tube to 3 tubes per treatment.
Aminolevulinic acid hydrochloride is implemented in combination with photodynamic therapy to treat actinic keratoses (AK), the most common pre-cancerous lesion of the skin that results from chronic sun exposure. Actinic keratosis may, if it remains untreated, become a squamous cell carcinoma.
The condition is taken less seriously than certain other skin conditions, despite potential for skin cancer. The unmet needs and importance of timing for actinic keratosis has been highlighted by Neal Bhatia, MD, in a previous HCPLive article.2
Biofrontera’s new sNDA is supported by the findings resulting from two phase 1 trials assessing the safety of this application of 3 tubes of the treatment.1
"The studies supporting this application showed robust safety parameters for the simultaneous use of three tubes, with systemic and application site adverse events equivalent to those with one tube," Hermann Luebbert, chief executive officer and chairman of Biofrontera Inc., said in a statement.
Subjects in 1 study were split by the investigators into 2 distinct cohorts: 1 was given PDT with 3 tubes of the treatment on the face or scalp, and the other on different parts of the body. This involved 32 total participants and evaluated the blood levels of 5-aminolevulinic acid and its active metabolite protoporphyrin IX (PpIX), examining several different points in time for up to 10 hours after treatment.
Another safety trial involving a total of 100 participants undergoing PDT with 3 tubes of aminolevulinic acid hydrochloride was carried out afterward, contributing to the new sNDA.
Overall, the research team’s findings suggested that although blood concentrations of the active ingredient and metabolite were shown to have transiently risen following the 3-tube application, the concentrations stated far below levels linked to possible side effects.
The investigators found that adverse events, both at the application site and systemic, were shown to have mirrored those observed with a single tube. They noted that subjects would experience temporary inflammation and manageable levels of pain at the time of illumination.
“Many patients have actinic keratoses over large surface areas and the ability to treat these pre-cancerous lesions in one office visit is more convenient for patients and more efficient for their dermatologists,” Luebbert concluded. “Therefore, we believe this approval, if granted, will lead to increased use of Ameluz in the US.”
The FDA’s filing review is complete and officials may now begin the substantive review process for the company’s sNDA submission.