FDA Allows Specialty Pharmacies to Prefill Remodulin Into Remunity Pump
The U.S. Food and Drug Administration (FDA) granted an extra clearance to the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also known as the Remunity pump, allowing the system to be used with drug cassettes that have been prefilled by specialty pharmacies.
The Remunity system allows for constant, subcutaneous (under-the-skin) delivery of Remodulin, a prescription medicine that mimics the effects of prostacyclin, a natural compound that works as a vasodilator keeping blood vessels open.
The system has a small pump that is connected to a disposable, prefilled cassette. The pump has a service life of three years before it needs to be switched.
The Remunity system was approved by the FDA in 2019 with instructions for patient filling. This new, additional clearance allows specialty pharmacies to prefill cassettes with Remodulin, allowing a more precise and convenient method for PAH patients.
United Therapeutics anticipates launching the system by July.
Currently, United Therapeutics and DEKA are working on a new version of the system that will contain disposable components that are prefilled during the manufacturing process.
“We’re super ‘pumped’ about launching Remunity by Independence Day,” Martine Rothblatt, chairman and CEO of United Therapeutics, said in a press release. “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 Remunity system includes a wider range of notifications, alerts, and alarms than currently available pumps, Rothblatt said. The pump contains acoustic volume-sensing technology and a solid-state actuator, which allows Remodulin flow rates to be controlled without using a motor.
“To me, because of so few moving parts, it is like the Tesla of parenteral pumps,” Rothblatt said.
“We are excited to be launching this innovative delivery technology with United Therapeutics,” said Dean Kamen, founder and president of DEKA. “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 [United Therapeutics’] unique pharmaceutical advances.”