The U.S. Food and Drug Administration (FDA) has agreed to review a request to approve Trevyent (treprostinil) as a treatment of pulmonary arterial hypertension (PAH), United Therapeutics announced in a press release.
An FDA decision on this updated New Drug Application (NDA) for Trevyent is expected on or before April 27, 2020.
Correvio, which holds commercial rights to Trevyent outside the U.S. — including in Europe and the Middle East — is planning to file regulatory submissions for the therapy with the European Medicines Agency.
Trevyent is being developed by SteadyMed Therapeutics, a subsidiary of United Therapeutics. It consists of treprostinil, a synthetic analogue of prostacyclin that works by helping blood vessel walls to relax and so reduce the pressure inside of them, and a subcutaneous (under the skin) delivery system called PumpPatch.
PAH is characterized by constricted blood vessels linking the heart and lungs, preventing blood from being easily pumped through the lungs and from picking up sufficient oxygen.
In a 12-week, double-blind, placebo-controlled and multicenter trial in 470 patients with PAH, subcutaneous infusions of Trevyent were shown to improve patients exercise capacity, respiration, and overall quality of life.
But the agency declined a request for its approval, filed by Steady Med in August 2017, citing insufficient supporting data. Specifically, it requested more information on the specifications and performance testing of the PatchPump device.
PatchPump is a disposable, electronically controlled, pre-filled and pre-programmed device that delivers a two-day supply of treprostinil subcutaneously.
The FDA did not require further clinical trials into Trevyent, including use of the PumpPatch system, Steady Med announced in a March 2018 press release.