KORU Medical Systems, Inc. announced that it received U.S. Food and Drug Administration (FDA) clearance for use of the FREEDOM60(R) Infusion System with Hizentra(R) 50 mL prefilled syringes (PFS). The FREEDOM(TM) Infusion System is the first and only infusion system cleared for use with prefilled syringes and, given the majority of patients are prescribed doses of 50 mL or greater, this clearance for FREEDOM60(R) significantly expands the benefits of PFS use, especially for those diagnosed with conditions requiring significantly higher doses of immunoglobulin. When using prefilled syringes with the FREEDOM(TM) Infusion System, KORU Medical has demonstrated that patients can experience up to an 80% reduction in drug preparation tasks when compared to using vials.

The FDA approved the Hizentra(R) 50 mL prefilled syringe in April 2023, and CSL Behring has announced an early 2024 availability. Hizentra(R) is the most prescribed subcutaneous immunoglobulin and the first to be available in prefilled syringes.