Takeda’s Subcutaneous Immunoglobulin Receives FDA Approval for Maintenance Therapy of Rare Neuromuscular Disorder

Takeda has received FDA approval for HYQVIA (immune globulin infusion 10% [Human] with recombinant human hyaluronidase) for treating chronic inflammatory demyelinating polyneuropathy (CIDP), a rare, acquired, immune-mediated neuromuscular disorder. A subcutaneous immunoglobulin (IG), HYQVIA is meant for the maintenance treatment of CIDP to prevent the relapse of neuromuscular disability and impairment in adults.

According to a Jan. 16, 2024 company press release, HYQVIA is the only FDA-approved combination of IG and hyaluronidase, making it a facilitated subcutaneous IG (SCIG) infusion. With the hyaluronidase component, the therapy can be infused for adults with CIDP up to once monthly (every two, three, or four weeks). The hyaluronidase component facilitates the dispersion and absorption of large IG volumes in the subcutaneous space between the skin and the muscle, according to the press release.

Because of its subcutaneous delivery method, HYQVIA can be administered by a healthcare professional in a medical office, infusion center, or in the home. It can also be self-administered with proper training of the patient or caregiver.

HYQVIA first received US approval in 2014 to treat primary immunodeficiency in adults. This indication has since been expanded to include children two to 16 years old.

“With the FDA approval of HYQVIA for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalized maintenance treatment option for adults with this debilitating disease,” said Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit, in the press release. “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.”

“While it is considered the standard-of-care for maintenance treatment of adults with CIDP, IVIG [intravenous immunoglobulin] infusions may be challenging for some patients and their caregivers,” said Lisa Butler, executive director, GBS-CIDP Foundation International, in the release. “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 personalize treatment.”

Source: Takeda