Tuesday, July 16, 2024

Demyelinating Polyneuropathy Treatment: Takeda’s HYQVIA® Shows Long-Term Safety and Efficacy

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Takeda has presented favorable data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term study evaluating HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for chronic inflammatory demyelinating polyneuropathy (CIDP). The results demonstrate HYQVIA’s long-term safety, tolerability, and low relapse rate, reinforcing its effectiveness as a maintenance treatment for CIDP.

HYQVIA, the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, has shown impressive results in maintaining a stable disease course in patients with chronic inflammatory demyelinating polyneuropathy. Approved by the U.S. FDA and the European Commission, HYQVIA’s unique formulation allows high-volume immunoglobulin (IG) administration into the subcutaneous tissue, enabling once-monthly infusions. This treatment can be self-administered after appropriate training or administered by healthcare professionals.

Kristina Allikmets, SVP and Head of R&D for Takeda’s Plasma-Derived Therapies stated, “The ADVANCE-CIDP 3 trial further characterizes HYQVIA’s safety, efficacy, and tolerability profile, reinforcing its role as a long-term maintenance treatment. Our commitment to neuroimmunological disorders continues, providing effective treatment options that meet diverse patient needs.”

Long-Term Study Confirms HYQVIA’s Efficacy and Safety in Demyelinating Polyneuropathy Maintenance

The ADVANCE-CIDP 3 trial, the longest extension study for chronic inflammatory demyelinating polyneuropathy, included 85 patients from the initial ADVANCE-CIDP 1 trial. The primary outcomes focused on safety, tolerability, and immunogenicity, with a median treatment duration of 33 months. Key findings include a low adverse event rate and consistent safety profile. Most adverse events were mild or moderate and self-limiting.

Dr. Robert Hadden, Consultant Neurologist at King’s College Hospital and ADVANCE-CIDP 3 author, noted, “The study’s results provide additional confidence in HYQVIA’s potential for long-term maintenance of chronic inflammatory demyelinating polyneuropathy. This treatment offers the convenience of self-administration at home, typically once every four weeks.”

CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system, characterized by progressive weakness and sensory dysfunction. Immunoglobulin therapy is well-established as a standard treatment due to its immunomodulatory and anti-inflammatory effects. HYQVIA’s facilitated subcutaneous administration represents an innovative approach to managing this chronic condition, significantly improving patients’ quality of life.

Demyelinating Polyneuropathy

Long-Term Demyelinating Polyneuropathy Management with Unique Subcutaneous Infusion System

HYQVIA is a liquid medicine containing recombinant human hyaluronidase and immunoglobulins (IG). Approved for primary immunodeficiency (PI) and secondary immunodeficiency (SID), it is also used as maintenance therapy for chronic inflammatory demyelinating polyneuropathy after stabilization with intravenous immunoglobulin (IVIG). HYQVIA’s unique delivery system facilitates the dispersion and absorption of IG in subcutaneous tissue, allowing up to monthly infusions.

The ADVANCE-CIDP 3 trial extended the Phase 3 ADVANCE-CIDP 1 study, assessing HYQVIA’s long-term safety, tolerability, and immunogenicity in chronic inflammatory demyelinating polyneuropathy patients. The trial’s primary objective was to evaluate these parameters, while efficacy was an exploratory outcome. The trial’s results affirm HYQVIA’s role in managing CIDP over extended periods.

Takeda continues to prioritize the development of innovative treatments for rare neuroimmunological disorders. The company’s extensive pipeline and commitment to research aim to address the diverse needs of patients worldwide. By focusing on long-term safety and efficacy, Takeda strives to improve the quality of life for patients with complex conditions like chronic inflammatory demyelinating polyneuropathy.

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Resource: Takeda, June 18, 2024

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