Biofrontera files supplemental NDA to broaden Ameluz use for full‑body actinic keratosis
Biofrontera Inc. submitted a supplemental New Drug Application to the U.S. FDA to add mild‑to‑moderate actinic keratosis on the extremities, neck and trunk to the label of its Ameluz® 10% gel used with BF‑RhodoLED red‑light lamps. The filing is backed by a Phase 3 trial of 172 patients that showed 45.6% complete clearance of lesions versus 16.7% with vehicle. If approved, Ameluz would become the only FDA‑cleared photodynamic therapy for full‑body AK treatment.
Why it matters
The company says the expanded indication could increase market penetration and accelerate revenue growth, as the current label covers only the face and scalp. The FDA will conduct a 60‑day filing review before deciding on a substantive review.
Key facts
- 1Biofrontera submitted a supplemental NDA to the FDA to expand Ameluz® for AK on extremities, neck and trunk. globenewswire.com
- 2The Phase 3 trial enrolled 172 patients with AK on the extremities, neck and trunk. globenewswire.com
- 3In the trial, 45.6% of patients achieved complete clearance of treated AK lesions, compared with 16.7% for vehicle. globenewswire.com
- 4Treatment fields in the study ranged up to approximately 240 cm². globenewswire.com
- 5The FDA filing review period is 60 days. tradingview.com
- 6Biofrontera reported a 12% revenue growth for full‑year 2025 and about 25% growth in the first half of 2026. globenewswire.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.