20-12-2011: Biofrontera was informed by the European Commission that its product Ameluz® (in development called BF-200 ALA) was approved for distribution throughout the entire EU, Norway, Island and Liechtenstein. Already in October had the responsible "European Medicines Agency" recommended the approval that was now ratified.
Ameluz® is a prescription-only medicinal product for the treatment of actinic keratosis by the so-called photodynamic therapy. In such therapies a medicinal product, in this case Ameluz®, is combined with a light-treatment. Large pivotal clinical trials had demonstrated the strong superiority of Ameluz® in comparison to its competitors. With the EU-wide approval, Ameluz® can in principle be distributed immediately, but the manufacturing and the release of Ameluz® will still require some weeks. The first market launch, planned for Germany, is thus foreseen for the 1st of February.