Validation of the dossier for drug approval of Biofrontera's BF-200 ALA successful

04-Oct-2010 - Germany

Biofrontera AG announced that the European Medical Agency EMA has confirmed the successful validation of the drug approval dossier for BF-200 ALA. With this, the first phase of the approval process has been passed and the completeness, conformity with legal requirements, and technical quality of the electronic dossier confirmed. In the following intercept of the process the dossier will be reviewed by knowledgeable rapporteurs from two EU member states. The result of their review will be presented to the EMA and all other member states in December, such that a general assessment will be provided in January.

BF-200 ALA is foreseen for the treatment of actinic keratosis. The EMA has agreed to the eligibility for the centralized registration procedure due to the high innovation of the product. The centralized approval will be valid in all EU member states. Actinic keratoses are superficial skin tumours which develop further to spinal cell carcinomas in 10-15% of the patients. BF-200 ALA is applied together with a red-light illumination, a treatment that is called photodynamic therapy (PDT) and listed as first line therapy in the international guidelines for the treatment of actinic keratosis. Both pivotal phase III studies with BF-200 ALA demonstrated excellent results with respect to efficacy and cosmetic outcome.

"The successful validation without delay reflects the meticulous preparation of the filing dossier. Following the timely filing and the successful validation, we hope that the further registration process will also be according to plan and we receive the drug approval in less than one year," commented Prof. Hermann Lübbert, Biofrontera's CEO.

https://www.bionity.com/en/news/123807/validation-of-the-dossier-for-drug-approval-of-biofrontera-s-bf-200-ala-successful.html