In 2014, Baxter got HyQvia over the FDA finish line for patients with primary immunodeficiency (PI).
Eight years and three companies later, Takeda is finding more uses for the subcutaneous treatment.
On Thursday, the Japanese company reported successful results of a phase 3 trail of the drug as a maintenance treatment for another rare autoimmune disorder—chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
The double-blind study in 132 patients showed that HyQvia reduced relapse neuromuscular disability and impairment versus placebo. The patients in the treatment arm had received intravenous immunoglobulin (IVIG) therapy for at least three months prior to infusion with HyQvia.
When administered at the same dose and same dosing interval as IVIG, HyQvia reduced the number of patients who experienced CIPD relapse to about 10%. That compared with 32% for placebo.
“While the efficacy and safety of intravenous immunoglobulin therapy in CIDP is well-established, there is a substantial burden associated with chronic administration of therapies for patients,” Kristina Allikmets, who heads up Takeda’s R&D for its plasma-derived therapies, said in a statement. “There is a significant need for a treatment that is both efficacious and can be administered monthly at home or in the hospital with a reduced number of infusion sites and reduced administration duration and frequency.”
CIDP is a rare and chronic autoimmune disease that affects the peripheral nervous system. The condition results in progressive symmetric weakness and impaired sensory function in the arms and legs, Takeda said.
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Immunoglobulin therapy has become standard of care for CIDP patients due to its broad, multifaceted, anti-inflammatory and immunomodulatory effect.
Based on the results, Takeda said plans to submit applications for approval of HyQvia in the indication in the United States and Europe by the end of this year.
Takeda picked up the drug in 2018 when it acquired Shire. Before that, Shire bought Baxter's Baxalta spinoff in 2016.