Biotechnology company United Therapeutics Corporation (Nasdaq:UTHR) on Monday announced that it has received US Food and Drug Administration (FDA) additional 510(k) clearance for the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, or the Remunity pump, for the treatment of PAH.
The Remunity system, which was jointly developed by United Therapeutics and and DEKA Research & Development Corp, is indicated for continuous subcutaneous delivery of Remodulin to treat pulmonary arterial hypertension, or PAH, in adults greater than 22 years of age. The new upgraded Remodulin (treprostinil) Injection have been prefilled by specialty pharmacies.
According to the company, the Remunity includes a small, lightweight, ambulatory pump with an intended service life of three years, which the patient connects to a disposable prefilled cassette. Initially cleared in May 2019, the system came with instructions for patient filling.
This additional US FDA 510(k) clearance enables cassettes to be prefilled with Remodulin by contracted specialty pharmacies in order to improve convenience for patients. It plans to launch the Remunity system by July 2020.
In addition, the partnership's future version of Remunity will include disposable components prefilled in the manufacturing process.
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