Following the U.S. Food and Drug Administration’s (FDA) refusal last year to approve a new drug application (NDA) submitted by Trevyent’s licensor SteadyMed, a Cardiome partner, an agreement has been reached on the work needed to resubmit the NDA.
SteadyMed submitted the NDA in July 2017. In August, the FDA considered the submission to be incomplete and requested further data on specifications and performance testing for SteadyMed’s PatchPump device, the company’s drug-delivery technology.
After meeting with the FDA, SteadyMed now will add design verification and validation data.
The FDA requires no further clinical trials to prove the safety or effectiveness of Trevyent, according to a press release. SteadyMed expects NDA submission and acceptance to occur before the end of 2018.
Following the NDA resubmission, Cardiome said it plans to submit additional regulatory filings for Trevyent in Europe and Canada.
Trevyent’s active ingredient is treprostinil, a synthetic analogue of prostacyclin used to treat PAH.
PAH is characterized by constricted blood vessels connecting the heart and lungs. Prostacyclin is a vasodilator, and one of the most effective known compounds to have a preventive effect on blood vessels, keeping them from becoming constricted and avoiding clumping of blood platelets.
SteadyMed’s PatchPump is a small, disposable, electronically controlled, pre-filled drug-delivery device. It can deliver treprostinil subcutaneously or intravenously, and gives patients audible and visual clues so that they know when the drug is being delivered.
In June 2015, SteadyMed announced the licensing of Trevyent’s commercial rights to Cardiome in specific markets outside the U.S., including Canada, Europe, and the Middle East. The licensing was dependent on approval in these international markets.
“Cardiome achieved a number of important milestones in 2017” said William Hunter, MD, CEO and president of Cardiome. “In parallel with our regulatory and sales goals, we continue to pursue business development opportunities that leverage our leadership position in commercialization of proprietary, in-hospital drugs outside the United States,” he said.
Trevyent received orphan drug status from the FDA for the treatment of PAH in January 2016.
In April 2017, a study conducted by SteadyMed showed that the PatchPump technology delivering Trevyent was effective, safe and well-tolerated. In the following month, SteadyMed received a patent for its PatchPump infusion system for injectable drugs, including Trevyent, from the U.S. Patent and Trademark Office.