Takeda Announces Positive Topline From Pivotal Trial For Autoimmune Disease

Takeda has announced that Hyqvia, a monthly infusion for the maintenance treatment of a rare nervous autoimmune disease, has met its primary endpoint in a pivotal trial.

Topline data indicate Hyqvia reduced relapse of neuromuscular impairment when used as a maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), which affects the peripheral nervous system. 

The infusion, given once every three to four weeks, is intended to reduce the number of infusion sites, as well as the duration and frequency of administration. 

Hyqvia is currently only approved for primary immunodeficiency (PI) in adults. Later in 2022, Takeda intends to file for approval of Hyqvia, once the full data from its trials are out. 

Reducing CIDP Relapse 

CIDP progressively weakens and impairs the sensory function and movement in the arms and legs. IVIG treatment is the standard of care for CIDP patients given its anti-inflammatory and immunomodulatory effect. However, frequent, chronic administration creates a burden on patients.

Hyqvia is immune globulin infusion 10% (human) with recombinant human hyaluronidase that is infused as a subcutaneous solution. 

Results from Hyqvia’s Phase 3 clinical trial, Advance-1, showed that the drug reduced CIDP relapse compared to the placebo (9.7% vs 31.4%). Most of the 132 adult CDIP patients received a four-week dosing regimen of Hyqvia. Previously, the patients were on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for the last three months before Hyqvia infusion. 

While the efficacy and safety of IVIG therapy is well-established, there is substantial burden associated with chronic administration, said Kristina Allikmets, Head of Research and Development for Takeda’s Plasma-Derived Therapies Business Unit. 

Hyqvia could meet the significant need for an effective treatment that can be given at home or in the hospital with a reduced number of infusion sites and reduced administration duration and frequency, Allikmets said. 

In the analyses of Advance-1, Hyqvia also showed a favorable safety profile, with most adverse events related to the treatment reported as mild or moderate. 

That said, the medicine comes with a warning about thrombosis, which may occur with immune globulin (IG) products. Hyqvia is also contraindicated in patients with hypersensitivity or antibody-based issues to human IG. 

The safety profile of Hyqvia will be more clearly elucidated once results from the Advance-3 clinical trial is out. The study aims to follow some patients up to six years, and is the longest extension study of its kind. 

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Joy Lin

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