When is ameluz pdt will be reviewed by fda

Ameluz® Photodynamic Therapy (PDT) is expected to be reviewed by the FDA in October 2024. This review is in relation to a Supplemental New Drug Application (sNDA) submitted by Biofrontera Inc. to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. The sNDA is supported by two Phase 1 safety studies and aims to treat actinic keratosis (AK) fields with up to three tubes. The FDA has set a target action date of October 4, 2024, for the review of this sNDA.

1. Target Action Date: The FDA has set a target action date of October 4, 2024, for the review of Biofrontera's sNDA to increase the dosage of Ameluz® PDT from one to three tubes per treatment.
2. Safety Studies Support: The sNDA is supported by two Phase 1 safety studies that demonstrate robust safety parameters for the simultaneous use of three tubes, which is equivalent to the safety profile of using one tube.
3. Patient Convenience and Efficiency: Many patients with actinic keratoses have large surface areas affected, and treating these pre-cancerous lesions in one office visit is more convenient for patients and more efficient for their dermatologists. The increased dosage, if approved, is believed to lead to increased use of Ameluz® PDT in the United States.
4. Market Potential: Actinic keratosis is a common skin condition that affects an estimated 13 million treatments annually in the US. If the FDA approves the increased dosage, it could expand the market potential for Ameluz® PDT, which is already FDA-approved for the treatment of actinic keratosis on the face and scalp.

The review of Ameluz® PDT's sNDA in October 2024 is a significant event for Biofrontera and the dermatological community, as it could lead to broader use of the therapy and improved patient care if the FDA approves the increased dosage.