Posted by Michael Wonder on 11 Dec 2016
Cardiorentis’ ularitide receives FDA fast track designation for the treatment of acute decompensated heart failure
11 December 2015 - TRUE-AHF phase III top line results anticipated in spring 2016.
Cardiorentis AG today announced that the U.S. FDA has granted fast track status to ularitide, an investigational therapy for the treatment of acute decompensated heart failure.
The FDA’s fast track process is intended to facilitate the development and expedite the review of drugs for the treatment of serious conditions addressing an unmet medical need.
Cardiorentis expects to file a U.S new drug application and European marketing authorisation application in the second half of 2016.
