FDA 510(k) approval for Unity Subcutaneous Delivery System for Remodulin Injection to treat pulmonary arterial hypertension
United Therapeutics Corporation and DEKA Research & Development Corp. announced receipt of 510(k) clearance by the FDA for the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also referred to as the RemUnity system.
The RemUnity system, which has been jointly developed by United Therapeutics and DEKA, 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.
Comment: The lightweight pump controls the drug’s flow rates without the use of a motor using acoustic volume sensing technology and a solid-state actuator. The pump has a service life of at least three years.
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