The US FDA has approved Hyqvia as a maintenance therapy to inhibit the relapse of neuromuscular disability and impairment in adults
Takeda’s office in Cambridge, Massachusetts, US. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has secured the US Food and Drug Administration (FDA) approval for Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] to treat certain adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
Hyqvia is a liquid medication with Recombinant Human Hyaluronidase and immunoglobulin (IG).
The US FDA has approved Hyqvia as a maintenance therapy to inhibit the relapse of neuromuscular disability and impairment in adults.
The medicine secured US approval in 2014 to treat primary immunodeficiency (PI) in adults, which has since been extended to include children aged two-16 years.
Takeda plasma-derived therapies business unit president Giles Platford said: “With the FDA approval of Hyqvia for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, 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.”
The approval was based on findings from the ADVANCE-CIDP 1 trial that assessed the efficacy and safety of Hyqvia as a maintenance therapy in adults with CIDP.
The efficacy evaluation consists of 122 adults from ADVANCE-CIDP 1 who had a verified diagnosis of CIDP and had been on a consistent intravenous immunoglobulin (IVIG) therapy dosage for a minimum of three months before screening.
According to the analysis of the primary endpoint, a statistically significant difference in the recurrence rates between the Hyqvia group and the placebo group was found.
The treatment difference of -18.3% showed that the drug was more effective than a placebo in avoiding CIDP relapse.
In December 2023, Takeda announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended Hyqvia’s approval as a maintenance treatment for patients with CIDP.