FDA Approves Actinic Keratosis Therapy

The FDA has approved Biofrontera’s topical prescription drug BF-200 ALA (Ameluz) and medical device BF-RhodoLED.

The products may be used for photodynamic therapy treatment of mild to moderate actinic keratosis on the face and scalp.

Actinic keratosis is characterized by lesions (often on the face, scalp, lips, arms, and hands) caused by frequent exposure to the sun’s ultraviolet rays. Patients with actinic keratosis may develop rough, scaly patches of skin. If left untreated, this may develop into squamous cell carcinoma.

“We are extremely pleased with the FDA’s decision to approve Ameluz and BF-RhodoLED for the treatment of actinic keratosis,” said Hermann Luebbert, CEO of Biofrontera, in a press release. “We expect early adoption from dermatologists as we showcase the response rates of guideline-compatible field treatment, which is not covered by the label of competing technology.”

Biofrontera plans to launch Ameluz and BF-RhodoLED by September 2016.

In studies, Ameluz proved superior to standard of care, with a complete patient response rate of 91% when paired with BF-RhodoLED. Ameluz also led to low recurrence over the course of 12 months.

The most common adverse effects associated with Ameluz were headache, skin tension, increased sensitivity to pain, and warmth.

More than 58 million Americans are affected by actinic keratosis.