SteadyMed Plans to File FDA New Drug Application for PAH Therapy Trevyent

SteadyMed Therapeutics recently reported its strategic goals and priorities for 2017, including plans to file a New Drug Application (NDA) to market Trevyent in the U.S., the company’s lead candidate to treat pulmonary arterial hypertension (PAH).

Trevyent is based on treprostinil, the only parenteral therapy for PAH approved by the U.S. Food and Drug Administration (FDA) for both intravenous and subcutaneous use. In Trevyent, treprostinil is delivered using SteadyMed’s pre-filled, pre-programmed PatchPump technology. The Trevyent PatchPump is equipped with sensors that give the patients audible and visual feedback.

If the FDA grants Priority Review status to SteadyMed’s NDA for Trevyent, the company said it’s possible the FDA will approve commercial sale of the therapy by the end of the year. If Trevyent is approved, SteadyMed will seek Orphan Drug exclusivity from the FDA, securing seven years of market exclusivity.

SteadyMed is also continuing its commitment to raise awareness of PAH through its BePhenomenal community support program. The BePHenomenal program provides support to PAH patients and their loved ones while raising awareness for disease. More information about the program can be found at www.BePhenomenal.com.

“2017 is expected to be a pivotal year for SteadyMed as we focus our resources on key strategic goals and priorities related to the approval of our lead drug product candidate Trevyent,” Jonathan Rigby, president and CEO of SteadyMed, said in a press release. “We are confident that we can execute on these initiatives and priorities.”

“With our existing cash, plus the $10.7 million that is callable upon achievement of certain milestones per the second tranche of our last private financing, we can fund operations for at least the next twelve months. We are now eagerly looking forward to the commercial launch of Trevyent, if approved, in 2018,” he added.

SteadyMed also hopes for a favorable ruling this year in its Inter Partes Review (IPR) challenge against a U.S. patent currently owned by United Therapeutics. The IPR is a procedure conducted by the Patent Trial and Appeal Board for challenging the validity of a U.S. patent before the U.S. Patent and Trademark Office (USPTO).