FDA to Review Drug-Device Combo for Pulmonary Arterial Hypertension Treatment

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent (treprostinil), a drug-device combination product for the treatment of pulmonary arterial hypertension (PAH). 

Trevyent contains treprostinil, a vasodilatory prostacyclin analogue. It works primarily through vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation. The novel drug-device product administers treprostinil in a new parenteral delivery form, using the Company’s proprietary PatchPump technology. 

The PatchPump is a single-use, 2-day disposable drug delivery platform that is prefilled and preprogrammed with treprostinil at the correct administration rate. Sensors located on the PatchPump aid patients through visual and audible cues to demonstrate complete delivery and end of dosing.

A Prescription Drug User Fee Act (PDUFA) date of April 27, 2020 has been assigned to the Trevyent NDA. 

For more information visit unither.com.