Normal Human Immunoglobulin (CSL Behring)

Takeda (TSE:4502/NYSE:TAK) reported that TAK-881, an investigational immune globulin subcutaneous 20% formulation facilitated by recombinant human hyaluronidase, met its primary endpoint in a pivotal Phase II/III trial in primary immunodeficiency disease, demonstrating pharmacokinetic comparability to Hyqvia (immune globulin infusion 10% with recombinant human hyaluronidase) while delivering the equivalent immunoglobulin dose in half the infusion volume. The TAK-881-3001 trial is a pivotal Phase II/III, open-label, randomized crossover study evaluating TAK-881 against Hyqvia in adults and pediatric patients aged two years and older with PID who had previously received immunoglobulin therapy. TAK-881-3001 met its primary endpoint of pharmacokinetic equivalence, with a geometric mean ratio of 99.67% for AUC0-tau,ss — the area under the IgG concentration-time curve over one dosing interval at steady state — with a 90% confidence interval of 95.10% to 104.46%, falling within the prespecified equivalence bounds. Secondary endpoints showed comparable infection rates and immune protection, with protective IgG levels maintained throughout the study. The safety and tolerability profiles were also comparable to Hyqvia, with no new safety signals identified. TAK-881 is composed of a 20% immunoglobulin solution co-administered with Halozyme’s rHuPH20 enzyme, which transiently degrades hyaluronan in the subcutaneous extracellular matrix, increasing tissue permeability and enabling larger infusion volumes at a single site. Hyqvia, the established comparator and current Takeda-marketed product, uses the same delivery mechanism but at a 10% immunoglobulin concentration. The doubling of concentration in TAK-881 is what allows the same IgG dose to be delivered in half the volume, with the potential to shorten infusion duration while preserving the up to once-monthly dosing schedule — every three or four weeks for PID — that distinguishes facilitated subcutaneous immunoglobulin from conventional weekly or biweekly subcutaneous regimens. The primary immunodeficiency disease treatment landscape is crowded with approved options spanning intravenous and subcutaneous formulations from CSL Behring, Grifols, Octapharma, and Takeda itself, but the facilitated subcutaneous segment remains narrow. Hyqvia, approved in the US for adults and children aged two and older with PID, is the only currently approved fSCIG product, and TAK-881 is being developed explicitly as a next-generation candidate within that same mechanistic class. Cross-trial comparisons are limited by differences in patient populations, study designs, and endpoints, but within Takeda’s own portfolio, TAK-881 would sit above both Hyqvia and the conventional SCIG product Cuvitru (immune globulin subcutaneous 20%) in terms of per-infusion volume efficiency. The trial enrolled participants across two distinct arms. Adults and patients aged 16 and older were randomized in an open-label crossover design, receiving TAK-881 followed by Hyqvia or the reverse sequence, with the same dose and dosing interval maintained for up to 51 weeks. Pediatric patients aged two to under 16 were enrolled in a separate open-label single-arm segment and treated with TAK-881 only for up to 27 weeks. This design reflects a pragmatic approach to a population where crossover against an active comparator in younger children raises both ethical and logistical complications, though the absence of a direct pediatric comparison with Hyqvia means the pediatric dataset will be interpreted primarily against historical benchmarks rather than concurrent controls. For patients requiring lifelong immunoglobulin replacement, the practical dimensions of therapy — infusion duration, number of needle insertions, and dosing frequency — carry weight alongside clinical outcomes. Conventional subcutaneous immunoglobulins such as Hizentra (immune globulin subcutaneous 20%) from CSL Behring or Xembify (immune globulin subcutaneous 20%) from Grifols require multiple infusion sites per session due to per-site volume constraints, typically necessitating weekly administration. Hyqvia addressed part of that burden by enabling single-site, once-monthly infusion, but sessions can still extend to several hours depending on dose. A 20% concentration formulation with the same hyaluronidase-facilitated platform could reduce that session time, though Takeda has not yet disclosed specific infusion duration data from TAK-881-3001. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”) , a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that its Freedom60® Infusion Pump, including adapter for use with 50 mL prefilled syringes, has achieved certification under the European Union Medical Devices Regulation (EU MDR 2017/745), enabling commercialization across the European Union. The Freedom60 Infusion Pump is designed to support dosing with 50 ml prefilled syringes, while the FreedomEDGE® Infusion System provides a compatible option for 20 mL prefilled syringe formats. Together, these systems offer clinicians and patients flexibility across dosing regimens while maintaining a consistent, intuitive user experience. EU MDR certification of both the Freedom60 and FreedomEDGE Infusion Pumps expands access to a system designed to support the growing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy and simplify the home infusion experience for patients. The increasing availability of prefilled syringe formats represents an important step forward in the evolution of SCIg therapy. Published studies have shown that prefilled presentations can: Reduce preparation and administration step vs vials 1 Minimize medication handling 1 Decrease overall treatment burden 2 Improve patient confidence and independence with home therapy 3 “EU MDR certification for the Freedom60 Infusion Pump marks an important step in expanding access to simpler, more patient-focused SCIg delivery across Europe,” said Linda Tharby, President and Chief Executive Officer of KORU Medical Systems. “As prefilled syringes become more widely adopted, patients are looking for solutions that reduce complexity and fit more easily into their daily routines. Our Freedom60 and FreedomEDGE systems are designed to meet that need - helping streamline therapy while maintaining the reliability that clinicians and patients expect.” About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the “Freedom System”) currently includes the Freedom60 ® and FreedomEDGE ® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Actual results may differ materially from these statements due to potential risks and uncertainties such as those included under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, which is on the SEC and available on our website at and on the SEC website at . All information provided in this release and in the attachments is as of March 13, 2026. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. CSL Behring LLC. Hizentra® PI 10 g Prefilled Syringe Leave-Behind (Document No. USA-HPI-0042 ; USA-HPI-0042-DEC23). Approved Dec 21, 2023 . Mallick R, Solomon G, Bassett P, Zhang X, Patel P, Lepeshkina O. Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies – impact of drug packaging and administration method on patient reported outcomes. BMC Immunology. 2024;25:18. doi:10.1186/s12865-024-00608-0 Pandya D, Tavanti M, Hubsch A, Panaite A, Murphy E, Ramakrishna B, Mielke O. Successful simulation of infusion pump use for IgPro20 prefilled syringes. Poster 116. Presented at the Immunoglobulin National Society (IgNS) 13th National Conference; Oct 17–20, 2024; Washington, DC, USA. CSL Behring Medical Affairs. Contacts Investor Contact: Louisa Smith investor@korumedical.com