Faron Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for Traumakine, which also has the orphane status in Europe.
Traumakine is Farons product for the treatment of Acute Respiratory Distress Syndrome (ARDS), currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan). The results are expected in 1H 2018.
ARDS 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, sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron recruited 300 patients for the pan-European pivotal trial INTEREST in December 2017.
Dr Markku Jalkanen, CEO of Faron, said: “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 which is on track and due in H1 2018. In accordance with our wider strategy, we continue to accelerate our plans to enable rapid and broad commercial adoption of Traumakine.”