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FDA approval of Faron's Traumakine® IND
FDA approval of Faron's Traumakine® IND.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 7272C Faron Pharmaceuticals Oy 24 January 2018 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nFDA has approved Faron's Traumakine® IND\n \n \nTURKU - FINLAND, 24 January 2018 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, announces that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application for Traumakine, the Company's wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS), which is part of the regulatory process towards BLA submission. \n \nThe FDA has already proposed that Faron can proceed directly to Biologics License Application (BLA) pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) and the IND forms part of this process towards BLA submission. Faron also continues to consider providing access to Traumakine in the US to ARDS patients under an expanded access program, which requires an IND. Top-line data from the INTERST study is due in the first half of 2018. \n \nFaron is also planning to conduct a small open label study in the US for pharmacological purposes and the IND will allow opening of clinical activities in the US. This first US study will target Traumakine (drug product FP-1201-lyo) in moderate and severe ARDS patients, especially with end organ (kidney and liver) failures. \n \nARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%[1],[2],[3], 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. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron completed the recruitment of 300 patients with moderate and severe ARDS for the pan-European pivotal trial INTEREST in December 2017. \n \nDr Markku Jalkanen, CEO of Faron, said: \"We are very pleased to receive this IND approval from the FDA which will allow us to further advance our Traumakine plans in the US. It also allows rolling dossier build up for FDA, which can speed up the final BLA acceptance. With data expected in H1 2018 and, fol...