Faron Pharmaceuticals Ltd (LON:FARN) said the US Food & Drug Administration has proposed that the group can proceed directly to Biologics License Application (BLA) submission pending positive results from the two on-going Phase III trial results for Traumakine, its treatment for Acute Respiratory Distress Syndrome (ARDS).
The Finland-based biopharma company said that, in a letter it received on 1 September 2017, the FDA proposed that, subject to the agency being satisfied with data, the BLA application for Traumakine can be filed purely with data obtained from the ongoing trials running in Europe and in Japan.
READ: Faron Pharmacueticals' Traumakine study making good progress
Commenting on the FDA's advice, Dr Markku Jalkanen, Faron's CEO, said: "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.“
He added: “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."
In response to the news, Faron Pharma shares on AIM were 1.8%, or 12.5p higher at 712.5p in late morning trading.
No pharmacological treatment currently approved for ARDS
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 (e.g. following a pandemic influenza), sepsis, or significant trauma with around 300,000+ annual cases in Europe and US.
As the Phase III study nears completion, the group said plans to initiate an expanded access programme for Traumakine to start once the trial is closed to new patients, which will allow compassionate use of the treatment in eligible patients at European hospitals.
The company added that it is also considering providing this access to US ARDS patients.