FDA approves increase of Ameluz dosing from one to three tubes for actinic keratosis

Key takeaways:

• The supplemental new drug application approved for Ameluz topical gel 10% increases the maximal dose from one to three tubes.
• This was supported by two phase 1 studies.

The FDA has approved the supplemental new drug application for Ameluz topical gel 10% to increase the maximal dosage from one to three tubes per treatment of actinic keratosis, according to a Biofrontera press release.

Ameluz topical gel 10% (aminolevulinic acid hydrochloride, Biofrontera Inc.) is currently the only FDA-approved photodynamic therapy photosensitizer for both lesion-directed and field-directed treatment of actinic keratosis. Since AK may affect many areas of both the face and scalp, this approval allows for patients with AK who are undergoing photodynamic therapy to use Ameluz on larger surface areas and multiple sites.

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

The approval was supported by two phase 1 safety studies comprised of 116 patients who were treated with three tubes of Ameluz. Results showed that localized adverse events on the skin were equal to that of patients treated with one tube. Blood tests also displayed concentrations of the active ingredient that were significantly lower than a level that would cause adverse events.