FDA Approves Increased Dosage of Biofrontera’s Ameluz Topical Gel for Actinic Keratosis

Image Credit: Adobe Stock Images/TheWaterMeloonProjec

The FDA has approved an increased dosage of Biofrontera’s Ameluz Topical Gel, 10% from one to three tubes per treatment for patients undergoing photodynamic therapy (PDT) for actinic keratosis (AK) on the face and scalp. According to the company, the regulatory action was based on positive results from Phase I clinical safety studies. Biofrontera stated that this approval will offer healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing PDT for AK on the face and scalp, leading to greater convenience overall.¹

“We are delighted with the FDA’s decision to approve the use of up to three tubes of Ameluz per treatment,” stated Hermann Luebbert, PhD, CEO, chairman, Biofrontera Inc, in a press release. “We are now working with Medicare and commercial payers to obtain reimbursement for this label update and will notify our customers accordingly.”

Clinical trials for Ameluz included 116 patients and showed that the use of three tubes maintained similar safety and systemic exposure levels as with one tube. There were no reported increases in adverse events (AEs) associated with an increase in dosage. Blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which AEs are known to occur, according to the study investigators.¹

“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,” continued Luebbert, in the press release.

AK is considered to be the most common pre-cancerous skin lesion caused by chronic sun exposure that, if left untreated, could develop into life-threatening skin cancer.1 According to News Medical Life Sciences, the rate of AK in the United States is approximately 10.2% in females and 26.5% in males, with men being more likely to be affected by it. This can be a result of factors such as average time spent outside and diet.

In most cases, AK affects people with white or lighter skin, with a direct link to excessive exposure to UV radiation. This results in the elderly, people who live close to the equator, and those who spend a lot of time outdoors having a higher incidence rate of AK. It is prevalent in an estimated 90% of people over the age of 80 years, while there is only a prevalence of 10% in people aged between 20 and 30 years. Patients with darker skin are less likely to be affected, with black individuals only experiencing AK in rare instances. However, patients with darker skin are still at risk for cutaneous malignancies regardless of their risk level for AK.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, co-managing partner, Georgia Dermatology Partners, Atlanta, GA, in the press release.

References

1. FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment GlobeNewswire. October 7, 2024. Accessed October 7, 2024. https://www.globenewswire.com/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 Epidemiology. Accessed October 7, 2024. https://www.news-medical.net/health/Actinic-Keratosis-Epidemiology.aspx