Subcutaneous treprostinil to treat PAH

July 5, 2019 0 By FM

United Therapeutics and DEKA Research have received 510(k) clearance by the US FDA for the subcutaneous delivery System for treprostinil (Remodulin) injection.

Also referred to as the RemUnity system, the therapy is indicated for pulmonary arterial hypertension, or PAH.

The RemUnity system consists of a small, lightweight, durable pump that is intended to have a service life of at least three years. The system uses disposable cartridges, which are connected to the pump.

DEKA intends to submit a Special 510(k) filing to the FDA shortly to enable cartridges to be pre-filled with treprostinil by contracted specialty pharmacy distributors in order to improve convenience for patients. United Therapeutics intends to launch the product when this additional FDA clearance has been obtained.

The companies are also developing a version of the system that includes disposable cartridges that are pre-filled as part of the manufacturing process.

Treprostinil is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).