The Food and Drug Administration (FDA) has granted clearance for the use of prefilled drug cassettes with the Remunity™ Pump for Remodulin® (treprostinil; United Therapeutics and DEKA) system.
The pump system is indicated for continuous subcutaneous delivery of Remodulin, a prostacyclin vasodilator, for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise. It is also approved for patients who require transition from epoprostenol, to reduce the rate of clinical deterioration.
Prior to this clearance, the therapy had only been approved with instructions for the patient to fill the cassettes. In an effort to improve patient convenience, the cassettes will now be prefilled by contracted specialty pharmacies.
“The system provides a wider array of notifications, alerts, and alarms than current pumps,” said Dr Martine Rothblatt, Chairman and Chief Executive Officer of United Therapeutics. “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.”
United Therapeutics plans to launch the Remunity system by July 2020.
For more information visit remodulin.com.