31-01-2011: Biofrontera has received a positive interim report of the responsible committee of the European Medicines Agency (EMA) in the ongoing centralized approval process of BF-200 ALA for the treatment of actinic keratosis.
The "Committee for Medicinal Products for Human Use (CHMP)" provides applicants on day 120 of the centralized approval process with an intermediate opinion and the open questions of the agency. The opinion considers the expert reviews of the rapporteurs (see adhoc 16-12-2010) and additional questions of all other EU member states. In the approval process of BF-200 ALA for actinic keratosis no major objections were raised at this point that would seriously endanger the approval. The agency recommended approval under the provision that satisfactory responses are given to the list of questions.
Biofrontera plans to respond within the scheduled time frame. In the centralized approval process, to which BF-200 ALA is eligible due to its high level of innovation, the marketing authorization will be granted for all EU member states in a single step.
BF-200 ALA is a drug for the treatment of actinic keratosis, a form of superficial non-melanoma skin cancer. Large clinical trials demonstrated the excellent efficacy of the new medicinal product and its clear superiority over the most relevant marketed competitor product. Actinic keratosis constitutes a major medical problem with patient numbers constantly growing due to the demographic development and the increasing exposure to UV light. Every other consultation of dermatologists in the USA is already related to this disease. Biofrontera therefore foresees an enormous market potential for its new drug.
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 approv ... more
The European Medicines Agency (EMA) issued a favourable opinion on Biofrontera's marketing approval application for its new medicinal product BF-200 ALA for the treatment of actinic keratosis. There was no recommendation for a restriction or temporal limitation of the approval. The product ... more
Biofrontera has received a positive interim report of the responsible committee of the European Medicines Agency (EMA) in the ongoing centralized approval process of BF-200 ALA for the treatment of actinic keratosis.The "Committee for Medicinal Products for Human Use (CHMP)" provides applic ... more
The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutic ... more
Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-co ... more
The European Medicines Agency has published its 2012 annual report. The report highlights the main trends recently observed in the Agency’s activities. For the past few years, the Agency has received a stable number of initial marketing authorisation applications (MAAs) for human medicines, ... more
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. more