The U.S. Food and Drug Administration rejected the company’s New Drug Application for the device, which delivers Trevyent (treprostinil). It said SteadyMed needs to submit a new application that answers the questions it has.
SteadyMed submitted the original application in July 2017. It covered both the therapy and the delivery device.
SteadyMed teamed up with Cardiome Pharma to develop Trevyent, which helps PAH patients by widening blood vessels to increase flow.
The marketing application was based on clinical trial results showing that Trevyent was safe, effective and that patients tolerated it well. The FDA has granted Orphan Drug Designation to the therapy, and SteadyMed has received a U.S. patent for the PatchPump infusion system.
Regulators said the New Drug Application lacked specifications and performance testing information that could support Trevyent’s approval.
In addition to performance information, SteadyMed and Cardiome will provide the agency with more information on how the drug works in the body. No additional clinical trials will be needed to provide this information, the agency and companies agreed.
SteadyMed expects to complete the performance testing in mid-2018. It said it believes the FDA will accept the revised New Drug Application before the end of 2018.
The partners will include the additional information they are collecting in the marketing applications for Trevyent that they will submit to the European Medicines Agency and Health Canada. The plan is to submit these applications shortly after the resubmission to the FDA.
“Gaining clarity on the Trevyent NDA [New Drug Application] pathway and timing is an important, positive development for both SteadyMed and Cardiome,” Dr. William Hunter, Cardiome’s president and CEO, said in a press release.
“We believe Trevyent represents a better way to deliver treprostinil to patients around the world who are suffering from PAH, and we will continue to work diligently to prepare our planned regulatory filings for Europe and Canada,” he added.