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FDA advises Faron to proceed directly to BLA
FDA advises Faron to proceed directly to BLA.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 6634P Faron Pharmaceuticals Oy 04 September 2017 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nFaron announces that US FDA proposes proceeding directly to BLA submission for Traumakine® following completion of European and Japanese Phase III studies\n \n \nTURKU - FINLAND, 4 September 2017 - Faron Pharmaceuticals Ltd (\"Faron\") (LON: FARN), the clinical stage biopharmaceutical company, today announces that the FDA has proposed that Faron can proceed directly to Biologics License Application (BLA) submission pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) with the Company's wholly-owned product, Traumakine® for the treatment of Acute Respiratory Distress Syndrome (ARDS). In the letter received on 1 September 2017, the FDA proposed that, subject to the FDA being satisfied with data from the trials, the BLA application for Traumakine can be filed purely with data obtained from the ongoing trials outside of the US. In the event of positive outcomes of the ongoing trials this FDA feedback is therefore expected to shorten the time for approval of Traumakine in US.\n \nCommenting on the FDA's advice, Dr Markku Jalkanen, CEO of Faron, said: \"We welcome the news that the FDA have proposed that we proceed directly to BLA submission for the US development of Traumakine. This important feedback potentially speeds up the regulatory approval process in the US and brings us one step closer to delivering Traumakine to patients in the world's largest pharmaceutical market. There is currently no approved pharmaceutical treatment for ARDS and Traumakine has the potential to address a significant unmet medical need in terms of mortality and savings for society. We now eagerly await the outcome of our ongoing Phase III trials and continue to build our presence in the US.\"\n \nARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma with around 300,000+ annual cases in Europe and US.\n \nAs the INTEREST Phase III study nears completion...