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FDA grants Fast Track Designation for Traumakine®
FDA grants Fast Track Designation for Traumakine®.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 1271D Faron Pharmaceuticals Oy 29 January 2018 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nFDA grants Fast Track Designation to Faron for Traumakine®\n \nFaron's wholly-owned product for Acute Respiratory Distress Syndrome on track for Phase III data in H1 2018\n \nTURKU - FINLAND, 29 January 2018 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, announces it has received Fast Track designation from the US Food and Drug Administration (FDA) for Traumakine®, the Company's wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS). Traumakine is currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan), with top-line data from the INTEREST study on track for the first half of 2018.\n \nFast Track designation is granted by the FDA to expedite the review and facilitate the development of drugs to treat serious conditions with significant unmet medical need. The purpose of the process is to get new drugs to patients quicker. Today's announced Fast Track designation is in addition to Traumakine's Promising Innovative Medicines (PIM) designation from the MHRA, which is the first stage of the MHRA's Early Access Medicines Scheme (EAMS). \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 that the FDA has granted Fast Track designation for Traumakine. This represents significant additional recognition of the potential that our drug holds to save lives and, in turn, relieve pressure and costs for healthcare systems. With Fast Track designation in the US, and PIM status in the UK, Traumakine is now ideally placed for an expedited route to market, following the top-line data w...