Takeda’s HyQvia has been approved by the US Food and Drug Administration (FDA) to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neuromuscular disorder affecting five to seven people per 100,000 in the US.
HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) can now be used as a maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults with CIDP.
Affecting the peripheral nervous system, CIDP is typically characterised by progressive symptoms, including weakness or loss of feeling in the arms and legs, loss of reflexes and difficulty walking.
Immunoglobulin (IG) therapy is considered the standard-of-care for maintenance treatment of adults with CIDP. However, there are aspects of intravenous IG treatment that can be challenging for patients, including long treatment durations, the potential for venous access challenges and infusion setting limitations.
HyQvia, which is the only FDA-approved combination of IG and hyaluronidase, is delivered as a subcutaneous infusion up to once monthly. It can be administered by a healthcare professional or self-administered, following appropriate training.
The therapy received its first US approval in 2014 to treat primary immunodeficiency in adults, which has since been expanded to include children aged two to 16 years.
The FDA’s latest decision was supported by positive results from the late-stage ADVANCE-CIDP 1 study, which demonstrated a statistically significant difference in relapse rate in favour of HyQvia versus placebo at six months.
Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit, said: “With the FDA approval of HyQvia for CIDP… we can now offer a personalised maintenance treatment option for adults with this debilitating disease.
“Research and clinical experience have shown that IG therapy is effective as maintenance treatment in adults with CIDP, and we hope that this approval for HyQvia is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.”
Lisa Butler, executive director, GBS-CIDP Foundation International, added: “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalise treatment.”