Press release
United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin®
~ Remunity™ expected to be available for patients by July 2020 RESEARCH TRIANGLE PARK, N.C. and MANCHESTER, N.H., Feb. 24, 2020 /PRNewswire/ -- United
About this update from United Therapeutics Corporation
[{"type":"text","content":"~ Remunity™ expected to be available for patients by July 2020\n\n\nRESEARCH TRIANGLE PARK, N.C. and MANCHESTER, N.H., Feb. 24, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) and DEKA Research & Development Corp. today announced receipt of an additional 510(k) clearance by the U.S. Food and Drug Administration (FDA) related to the Unity Subcutaneous Delivery System for Remodulin® (treprostinil) Injection, also referred to as the Remunity™ pump, enabling United Therapeutics to launch the system using drug reservoirs that have been prefilled by specialty pharmacies. \n\n \n \n\n \nThe Remunity system, which was jointly developed by United Therapeutics and DEKA, is indicated for continuous subcutaneous delivery of Remodulin to treat pulmonary arterial hypertension, or PAH, in adults greater than 22 years of age. 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. \nThe system was initially cleared by the FDA in May 2019 with instructions for patient filling. This additional 510(k) 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 are also developing a future version of the system that will include disposable components that are prefilled as part of the manufacturing process.\n\"We're super 'pumped' about launching Remunity by Independence Day,\" said Dr. Martine Rothblatt, Chairman and Chief Executive Officer of United Therapeutics. \"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!\" \n\"We are excited to be launching this innovative delivery technology with United Therapeutics. We are confident that the Remunity system, particularly with the addi...