Posted by Michael Wonder on 05 Jul 2017
Cardiome' partner SteadyMed submits U.S. new drug application for Trevyent for the treatment of pulmonary arterial hypertension
3 July 2017 - Cardiome Pharma Corporation today announced that partner SteadyMed submitted a new drug application to the U.S. FDA for Trevyent (treprostinil injection).
Trevyent is a drug-device combination product that utilises SteadyMed’s PatchPump technology to deliver treprostinil, a vasodilatory prostacyclin analogue, for the treatment of pulmonary arterial hypertension.
PatchPump is a proprietary, disposable, parenteral drug administration platform that is pre-filled and preprogrammed at the site of manufacture. Cardiome licensed the commercial rights to Trevyent for many international markets in June 2015. Cardiome expects to file Trevyent for EMA and Health Canada approval by the end of 2017.
