United Therapeutics, DEKA get FDA OK for subcutaneous delivery system for Remodulin
Patients with pulmonary arterial hypertension will shortly have a more convenient way to treat their disease. United Therapeutics and DEKA Research & Development have received the Food and Drug Administration’s blessing for the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also known as the Remunity pump. This enables United Therapeutics to launch the system using drug reservoirs that have been prefilled by specialty pharmacies.
The Remunity system, which was jointly developed by United Therapeutics and DEKA, is indicated for continuous subcutaneous delivery of Remodulin to treat pulmonary arterial hypertension in adults 22 years old and older. The Remunity system includes a small, lightweight, ambulatory pump with an intended service life of three years, which the patient connects to a disposable prefilled cassette.
The system was initially cleared by the FDA in May 2019 with instructions for patient filling. This additional clearance enables cassettes to be prefilled with Remodulin by contracted specialty pharmacies in order to improve convenience for patients. United Therapeutics plans to launch the Remunity system by July 2020. United Therapeutics and DEKA also are developing a future version of the system that will include disposable components that are prefilled as part of the manufacturing process.
"We're super 'pumped' about launching Remunity by Independence Day," said Martine Rothblatt, United Therapeutics chairman and CEO. "Remunity will provide a new level of freedom to our patients through improved convenience, and we believe it will provide more free time to live their beautiful lives. The system provides a wider array of notifications, alerts, and alarms than current pumps. Most amazingly, 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. To me, because of so few moving parts, it is like the Tesla of parenteral pumps"
"We are excited to be launching this innovative delivery technology with United Therapeutics. We are confident that the Remunity system, particularly with the additional convenience of cassettes prefilled with Remodulin, has the potential to improve the lives of patients who depend on UT's unique pharmaceutical advances," said DEKA founder and president Dean Kamen. "We are extremely proud of UT's dedication to their patients and grateful to UT for their unwavering support of DEKA as we continue to develop and deliver advanced solutions to address the needs of those patients."