EMA approves BF-200 ALA
Leverkusen – One short statement from the European Medicines Agency (EMA) means one giant step for German biotech company Biofrontera. The agency issued a favourable opinion on the firm’s marketing approval application for its drug for the treatment of actinic keratosis. There was no recommendation for a restriction or temporal limitation of the approval. The substance, which Biofrontera had dubbed BF-200 ALA while in development, will now be marketed under the name Ameluz. The positive assessment report by the Committee for Medicinal Products for Human Use (CHMP) will now be forwarded to the European Commission for the formal conclusion of the process. Biofrontera anticipates final approval in December. After that, Ameluz can be commercialised in all 27 countries of the EU as well as Norway, Iceland and Liechtenstein, the company stated. Biofrontera began the application process in September of 2010.