This accelerated review is designed to get drugs to areas of unmet medical need.
The Faron treatment has thus far had an impressive impact on acute respiratory distress, which has a high mortality rate.
The US fast-tracking is a further validation of Traumakine’s potential. It recently received promising innovative medicines (PIM) designation from the UK regulator, which is the first stage to Medicines Healthcare Products Regulator Agency’s Early Access Medicines Scheme.
Trial read-out in the first-half
Traumakine is currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan), with release of top-line data from the former on track for the first half of this year.
Faron chief executive, Dr Markku Jalkanen, said he was very pleased with the FDA decision.
“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,” he explained.
“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.”
The company has repurposed beta interferon (a drug normally used to slow the progression of multiple sclerosis) to tackle acute respiratory distress (ARDS) with remarkable results.
ARDS is a little-known condition that can affect people of any age and usually develops as a complication of an existing serious illness such as flu, pneumonia, sepsis or even severe trauma.
It is so serious that the mortality rate is between 30-45% and there is no recognised pharmaceutical treatment.
Recently, the company completed the recruitment process for Phase III clinical assessment of Traumakine with the data from the INTEREST study expected sometime in the first half.
It was prompted to press on with development after some hugely impressive data gleaned from an earlier trial that received significant coverage in the prestigious Lancet medical journal revealed.
In the control group (i.e. those people who didn’t receive Traumakine) 32% died from ARDS.
That compares with an 8% mortality rate in the tranche of patients that received the new treatment.