Type of information: Granting of a Fast Track status
Product name: Traumakine®
Compound: FP-1201-lyo (the lyophilised form of Traumakine® (human recombinant interferon-beta 1a)
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
- protein. FP-1201 is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result is increased vascular leakage, which has been shown to be due to the lack of adenosine, an end product of AMP degradation by 5’-nucleotidase (CD73). Adenosine acts to enhance endothelial barrier function via adenosine receptor activation. Therefore, any biological substance, which acts to increase adenosine level, will reduce vascular leakage and be of benefit in ALI/ARDS patients. Such substances are type I interferons, and especially the interferon-beta (IFN-beta). IFN-beta has been shown to up-regulate 5’-nucleotidase (also known as a CD73 molecule and expressed abundantly by normal endothelial cells) and prevent ALI in animal models (Kiss et al. (2007) Eur. J. Immunol. 37:3334).
Company: Faron Pharmaceuticals (Finland)
Disease: acute respiratory distress syndrome (ARDS)
- • On January 29, 2018, Faron Pharmaceuticals announced it has received Fast Track designation from the FDA for Traumakine®, 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. Traumakine also has an orphan status in Europe, which normally expedites the review also at the European Medicine Agency (EMA). The Company also expects that Faron's partner in Japan, Maruishi will file an orphan application this year following the INTEREST trial read-out.
- • On October 2, 2017, Faron Pharmaceuticals announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicines (PIM) designation for its lead product, Traumakine® which is curently undergoing Phase III clinical trials for the treatment of Acute Respiratory Distress Syndrome (ARDS).
- • On September 4, 2017, Faron Pharmaceuticals announced that the FDA has proposed that Faron can proceed directly to Biologics License Application (BLA) submission pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) with Traumakine® for the treatment of Acute Respiratory Distress Syndrome (ARDS). In the letter received on 1 September 2017, the FDA proposed that, subject to the FDA being satisfied with data from the trials, the BLA application for Traumakine can be filed purely with data obtained from the ongoing trials outside of the US. In the event of positive outcomes of the ongoing trials this FDA feedback is therefore expected to shorten the time for approval of Traumakine in US.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2007-11-29
Pediatric exclusivit _USA:
Pediatric exclusivity UE: