FDA has now completed its mid-cycle review of the Ameluz® NDA (new drug application). The review resulted in no additional requests for material nor were any additional review issues highlighted.
Ameluz is a prescription drug used in combination with Biofrontera’s proprietary lamp, BF-RhodoLED, as a photodynamic therapy (PDT) to treat actinic keratosis.
Ameluz is currently approved in the EU and Switzerland. With European sales continuously growing, an approval in the USA would create a significantly larger market opportunity for Biofrontera.
The US market opportunity for Ameluz and BF-RhodoLED is particularly promising since PDT for actinic keratosis is a fully reimbursed Medicare procedure, which is not generally the case in Europe.
Biofrontera CEO Hermann Luebbert said: "The results of the mid-cycle review support our expectations. With this potential hurdle behind us, we do not anticipate any major delays and we look forward to FDA completing its review in the spring."