Biofrontera submits sNDA for Ameluz to increase max dosage for actinic keratosis treatment

Key takeaways:

• The company has requested that the maximally approved dosage for Ameluz increase from one to three tubes.
• The FDA has set a target action date of Oct. 4.

The supplemental new drug application for Ameluz has received a “no filing review issues identified” letter from the FDA, according to a press release.

Submitted by Biofrontera Bioscience GmbH, the supplemental new drug application (sNDA) requested that the maximally approved dosage for Ameluz (aminolevulinic acid hydrochloride), a topical indicated for the treatment of actinic keratosis (AK), be increased from one to three tubes per treatment.

The sNDA is supported by results from two phase 1 studies that evaluated the safety of utilizing three tubes vs. one of Ameluz to treat AK.

“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, PhD, CEO and chairman of Biofrontera Inc., said in the release. "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.”

In the first study, researchers monitored the blood concentrations of active Ameluz ingredients in 32 patients that were treated with three tubes of Ameluz and photodynamic therapy on the face and scalp and other parts of the body.

Results from this study showed that although the blood concentrations transiently increased, they were below the level at which side effects are known to occur. Further, all adverse events were similar to those observed with one tube of Ameluz.

A type A meeting with the FDA as well as a 100-patient safety trial were also used to support the sNDA submission.

The FDA has set a target action date of Oct. 4.