SteadyMed Gets Refuse-to-File Letter on Trevyent

FDA has issued SteadyMed Ltd. a Refuse-to-File letter on its NDA for Trevyent (treprostinil) for treating pulmonary arterial hypertension. The agency determined that the application is not sufficiently complete to permit a substantive review, according to the company. “FDA has requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product,” it says. Within the next 30 days, SteadyMed says it will request a Type A meeting with FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA.

Trevyent combines the company’s preservative-free, parenteral treprostinil formulation with its proprietary PatchPump in a sterile, pre-filled, pre-programmed, single use disposable infusion system capable of delivering the drug subcutaneously or intravenously.