United Therapeutics and DEKA Research & Development announced receipt of 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also referred to as the RemUnity™ system.
The RemUnity system is indicated for subcutaneous delivery of Remodulin to treat 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 RemUnity 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 Remodulin 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. United Therapeutics and DEKA are also developing a version of the system that includes disposable cartridges that are pre-filled as part of the manufacturing process.
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"We developed the RemUnity system to address safety and patient convenience problems with current subcutaneous infusion pumps," said Martine Rothblatt, Chairman and Chief Executive Officer of United Therapeutics. "We believe the RemUnity system reduces the risk of bolus dosing due to pump failures and provides wider arrays of notifications, alerts and alarms than current pumps. Most importantly, the acoustic volume sensing technology and solid-state actuator of the RemUnity system enables it to control Remodulin flow rates without the use of a motor."
"We are excited to be launching this innovative delivery technology with United Therapeutics. We are confident that it will substantially improve the lives of patients who depend on UT's unique pharmaceutical advances," said Dean Kamen, Founder and President of DEKA. "We look forward to continuing to deliver advanced solutions for patients in need."
Remodulin 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%).