FDA Approves sNDA for Actinic Keratosis Drug Dosage Expansion

Image Credit: © DermNet

Biofrontera Inc. announced today the FDA approval of a supplemental New Drug Application (sNDA) that increases the maximum allowable dosage of aminolevulinic acid hydrochloride (Ameluz) topical gel 10% from 1 tube to 3 tubes per photodynamic therapy (PDT) treatment session. The company stated this new dosage flexibility is expected to enhance treatment options for healthcare providers managing actinic keratosis (AK) in their patients.¹

Expanding AK Treatment Options

According to a release from the company, the FDA's approval of the sNDA provides health care professionals with increased flexibility to treat larger or multiple areas of AK. This change is particularly important given that AK is the most common precancerous skin lesion linked to chronic sun exposure, often found on sun-exposed areas such as the face, scalp, arms, and back of the hands.In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.²

“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. 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,” said Jonathan Weiss, MD, investigator and co-managing partner at Georgia Dermatology Partners in Atlanta in the release.

Clinical Support for Safety and Efficacy

The company stated that the sNDA approval was supported by 2 phase I safety studies that involved 116 patients. These studies assessed the application of 3 tubes of aminolevulinic acid hydrochloride topical gel 10% and confirmed that the blood concentrations of the active ingredient, as well as its metabolite, were several magnitudes lower than levels associated with known adverse effects. Furthermore, researchers found the systemic and application site adverse events reported were equivalent to those observed with the previously approved single-tube dosage, reinforcing the safety of the expanded use.

“Ameluz® is the only PDT photosensitizer indicated by the FDA for both lesion-directed and field-directed treatment of AKs. This 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®. It is another important milestone for Biofrontera as we continue to demonstrate our commitment to PDT and our dedication to the development of this important treatment modality,” Hermann Luebbert, PhD, chief executive officer and chairman of Biofrontera Inc., said in the release.

Implications for Patient Care and Future Directions

“We are delighted with the FDA’s decision to approve the use of up to 3 tubes of Ameluz® per treatment,” Luebbert wrote. “We are now working with Medicare and commercial payers to obtain reimbursement for this label update and will notify our customers accordingly.”

The company noted this ability to address larger treatment areas not only enhances the effectiveness of AK management but also aligns with thegrowing emphasis on preventive dermatology. Biofrontera stated that as dermatologists incorporate the new dosing regimen into their practices, they can look forward to providing comprehensive care for patients affected by actinic keratosis, ultimately enhancing patient outcomes in skin cancer prevention.

References

1. FDA approves use of up to three tubes of Biofrontera Inc.’s ameluz (aminolevulinic acid HCI) topical gel, 10% in one treatment. News Release. Global Newswire. Published October 7, 2024. Accessed October 7, 2024. https://www.globenewswire.com/en/news-release/2024/10/07/2958931/0/en/FDA-Approves-Use-of-Up-To-Three-Tubes-of-Biofrontera-Inc-s-Ameluz-aminolevulinic-acid-HCI-Topical-Gel-10-In-One-Treatment.html
2. Actinic keratosis overview: A common precancer. Skin Cancer Foundation. Accessed October 7, 2024. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,another%20name%20for%20the%20condition.