The Traumakine consortium announced today that it has received advise from the European Medicine Agency (EMA) for the clinical development plans of the FP-1201-lyo. According to the written advise, the EMA agreed to a large extent with proposed questions presented to the Agency. Faron had requested scientific advise for the pivotal pan-European clinical program to treat the acute respiratory distress syndrome (ARDS) with the intravenous recombinant human interferon beta-1a (FP-1201-lyo). The first of the two key aspects of the EMA request dealt with a new composite end point for the FPCLI002 study. The new composite end point combines both the all cause mortality at day 28 (D28) and ventilation free days among survivors during the same period, to provide a more comprehensive analysis of the ARDS patient outcomes during the treatment period. This approach was accepted by the EMA. The second aspect of the request proposed a new structure for the pivotal study. Instead of one large pivotal study the clinical development includes two smaller pivotal studies powered to each other via meta-analysis. This would allow a better pick-up of the treatment efficacy across these two dimensions. The first part will consist of 300 randomized and placebo controlled ARDS patients and the size of the second trial will be determined following the observed mortality (D28 and D90) difference between FP-1201-lyo treated and placebo groups. If the results of the first trial are overwhelmingly positive, a conditional marketing approval may be filed while executing the second trial. This will significantly speed up the final approval of FP-1201-lyo in Europe.
“We are very pleased that the EMA agreed to a large extent with our concerns about the clinical development of the FP-1201-lyo in Europe”, says Faron’s CEO and the Traumakine consortium coordinator Markku Jalkanen . “This advise will now set up our clinical development goals in Europe and we try to initiate the FPCLI002 trial as soon as we have all dossier parts in place,” adds Jalkanen. Faron has been granted an orphan drug status for the treatment of ALI/ARDS with interferon-beta by the European Commission and EMA.
The Consortium consists of the European Commission as a granting Agency, Faron Pharmaceuticals Ltd as the Coordinator and three other participating Partners of the Traumakine program, University College London Hospital (UCLH), University of Torino and University of Turku.
For more information, please visit:
http://www.faronpharmaceuticals.com
or contact:
Phone: +358-2-469-5151 (Coordinator)
E-mail: info@traumakine.eu