FDA Approves HyQvia as Maintenance Therapy for Rare Neuromuscular Disorder

The FDA has approved Takeda’s HyQvia as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent the relapse of neuromuscular disability and impairment.

CIDP is a rare neuromuscular disorder affecting the peripheral nervous system. It is characterized by progressive symptoms such as weakness, tingling or loss of feeling in the limbs, loss of reflexes and difficulty walking. Infusion with immune globulin provides antibodies to block the immune and inflammatory process that destroys myelin.

HyQvia is an immune globulin infusion with recombinant human hyaluronidase. The hyaluronidase part facilitates the dispersion and absorption of immune globulin in the subcutaneous space between the skin and the muscle. When used as maintenance for CICP, HyQvia is infused every two, three or four weeks.

The cost for Hyqvia subcutaneous solution is about $639 for a supply of 26.25 milliliters, according to Drugs.com. Dosing depends on the patient’s weight and previous treatments, which may impact the cost.

A spokesperson said the price is in line with value-based pricing principles, and The Takeda Patient Support team is available to assist patients.

“Takeda pricing principles consider variability in affordability, healthcare system maturity, out of pocket expenditure, GDP as well as other healthcare indicators across geographies,” she said.

Related: HyQvia Receives Expanded FDA Approval for Pediatric Primary Immunodeficiency

HyQvia first received approval in the United States in 2014 for the treatment of primary immunodeficiency in adults, which has since been expanded to include children 2 to 16 years old.

The approval for the CIDP maintenance indication is based on results from a placebo-controlled study, as well as a single-arm, open-label, extension study that evaluated the efficacy and safety of HyQvia as a maintenance therapy in adults with CIDP. The efficacy evaluation included 122 adults who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months before screening. In the study, HyQvia prevented more relapses placebo.