SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy.
The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system.
“The submission of our NDA for Trevyent is the latest in a series of significant milestones and accomplishments for SteadyMed thus far in 2017, and we are delighted that we are one major step closer to potentially making Trevyent available to patients suffering from PAH,” president & CEO Jonathan Rigby said in prepared remarks. “PAH is a serious, life threatening disease, and currently, the administration of high dose prostacyclins to help these patients has some serious challenges. Our drug product candidate, Trevyent, has been developed with the aim of addressing these challenges and we look forward to launching it in mid 2018, subject to FDA approval.”
Cardiome Pharma Corp. (NSDQ:CRME), which licensed the commercial rights to Trevyent for some international markets in June 2015, said that it expects to file for European Medicines Agency and Health Canada approval by the end of 2017.
“The NDA filing with the FDA is an important step in the development of Trevyent, and advances us closer to our goal of bringing what we believe is a better way to deliver treprostinil to patients around the world who are suffering from PAH,” Hugues Sachot, Cardiome’s chief commercial officer, added. “Our partnership with SteadyMed continues to progress well, and we will work closely with them to file with both the EMA and Health Canada by the end of this year.”
