OSAKA, JAPAN & CAMBRIDGE, MASS.--(Business Wire / Korea Newswire)--Takeda (TSE:4502/NYSE:TAK) today announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP. These findings will be presented in a poster session on Sunday, June 23, 2024 at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada.

HYQVIA is the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, approved earlier this year by the U.S. Food and Drug Association (FDA) as maintenance therapy in adults with CIDP and by the European Commission for patients of all ages with CIDP post-stabilization with intravenous immunoglobulin (IVIG). HYQVIA’s hyaluronidase component facilitates the dispersion and absorption of large immunoglobulin (IG) volumes in the subcutaneous space between the skin and the muscle. This allows high-volume IG administration (equivalent to volumes administered intravenously) into the subcutaneous tissue over a short time. As a result, HYQVIA can be infused up to once monthly (every two, three or four weeks). HYQVIA can be self-administered after appropriate patient or caregiver training or administered by a healthcare professional in a medical office, infusion center or at a patient’s home.[1]

“The long-term data from the ADVANCE-CIDP 3 clinical trial allow us to further characterize the safety, efficacy and tolerability profile of HYQVIA and reinforces its role as a long-term, up-to once monthly maintenance treatment for this complex, chronic condition,” said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “These results reflect our continued commitment to bringing the benefits of our differentiated immunoglobulin therapies to patients with neuroimmunological disorders, and providing a range of effective treatment options that address the individual needs of a broad range of patients.”

The ADVANCE-CIDP 3 clinical trial is the longest extension study ever performed within context of a clinical trial in CIDP to date. The study, which enrolled 85 patients from the ADVANCE-CIDP 1 clinical trial, evaluated the safety, tolerability and immunogenicity of HYQVIA. The primary outcome measure was safety/tolerability and immunogenicity. The median duration of HYQVIA treatment was 33 months (0 to 77 months) with a cumulative overall follow-up time of 220 patient years. The findings were consistent with the known safety and tolerability profile of HYQVIA and no new safety concerns were observed.[2] Key findings showed:

· The median monthly dose of HYQVIA across all patients was 64 (28.0 to 200.0) g/4 weeks.
· The mean infusion duration per dose of HYQVIA was 135.5 minutes with 88.2% of doses administered every 4 weeks and 92.3% of doses administered across two infusion sites.
· HYQVIA was well tolerated among the 3487 infusions administered; 3 (0.1%) infusions had a reduced infusion rate, were interrupted or stopped due to intolerability.
· Overall, adverse events (AEs) were reported in 89.4% of patients. AEs related to HYQVIA were reported in 60% of patients. Most AEs were mild or moderate and self-limiting, and consistent with the established safety profile of HYQVIA.
· The most common AEs per infusion (≥0.02 events per infusion) were headache, infusion site erythema, pyrexia, nausea, erythema, infusion site pruritis, fatigue and infusion site pain.
· Serious AEs possibly related to HYQVIA occurred in three patients (one event each): infection at the infusion site, exacerbation of migraine and fibromyalgia after infusion, and exacerbation of heart failure that resolved following treatment.
· HYQVIA maintained stable disease course in patients with CIDP. Thirteen percent of patients with data available experienced a relapse during the entire observation period with an annualized relapse rate of 4.5%.

“Results of the ADVANCE-CIDP 3 study help provide additional confidence to those living with CIDP and their healthcare providers regarding the potential for extended maintenance of their condition with a facilitated subcutaneous immunoglobulin,” said Dr. Robert Hadden, MD, Consultant Neurologist, Neurology Department, King’s College Hospital, London, UK and Department of Basic & Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK and ADVANCE-CIDP 3 presenting author. “This treatment allows the convenience of potential self-treatment at home, typically only once every four weeks.”

CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in the extremities.[3] The role of IG therapy for CIDP has been well-established[4] and is considered a standard of care for this complex and heterogeneous condition in guidelines from the European Academy of Neurology and Peripheral Nerve Society due to its broad immunomodulatory and anti-inflammatory effects.[5] Nearly a quarter of all IG therapy is used in the treatment of CIDP.[6]

About HYQVIA®
HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (IG) and is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of