8th Oct 2014 15:20
LONDON (Alliance News) - Biopharmaceutical company Biofrontera AG Wednesday said that it had a pre-new drug application meeting with the US Food & Drug Administration regarding the approval process for its Ameluz and BF-RhodoLED skin cancer treatment in the US, and all the questions raised were answered as proposed by the company.
The meeting marked a key step in the company's process of getting US approval for the drug and lamp therapy treatment, and it now expects to submits its application by the end of the first quarter of 2015 after getting the green light to proceed according to its plan.
Pre-new drug application meetings with the FDA represent the last opportunity for companies prior to submitting a drug approval to exchange positions about the approval pathway and content with the FDA. In preparation for the meeting, the FDA typically receives a package containing a summary of the application documentation as well as potential questions along with proposed answers and explanatory background.
Biofrontera said its application is particularly complicated because Ameluz and BF-RhodoLED have to be approved as combination of a drug and a medical device. Therefore, the company had raised 12 groups of questions covering regulatory, clinical, preclinical, production and quality aspects.
"Due to the high quality of the documentation which Biofrontera had provided in preparation of the meeting, only very few discussion points were left after the preliminary assessment of the FDA. In consequence, the meeting was held as a telephone conference, following a proposal by the FDA. During the discussion the participants reached agreement in all points. Most importantly, no additional studies were requested," it said in a statement.
Amelux is already approved for use in Europe as a prescription drug for the treatment of mild to moderate Actinic Keratosis, or superficial skin cancer, by light therapy. Biofrontera is looking to further develop Ameluz for use in Basal Cell Carcinoma. BF-RhodoLED is the lamp used for its light therapy.
Biofrontera shares were down 2.5% at 2.92 pence late Wednesday.
By Steve McGrath; [email protected]; @stevemcgrath1
Copyright 2014 Alliance News Limited. All Rights Reserved.
Related Shares:
B8F.L