Takeda wins expanded approval for immunodeficiency drug

Jan. 17, 2024

Takeda has received FDA approval for the expanded use of HyQvia in treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

Initially approved in 2014 for primary immunodeficiency, HyQvia is now the only FDA-approved combination of immunoglobulin and hyaluronidase for subcutaneous infusion, providing an alternative maintenance therapy option for adults with CIDP, a neurological disorder that involves progressive weakness in the arms and legs. 

HyQvia allows for facilitated subcutaneous immunoglobulin (SCIG) infusion, offering a monthly treatment schedule for CIDP patients. The hyaluronidase component aids in dispersing and absorbing large immunoglobulin volumes in the subcutaneous space, enabling administration in various healthcare settings, including medical offices, infusion centers, or at home. Health care professionals or adequately trained patients can now administer the treatment.

The FDA nod is based on results from the ADVANCE-CIDP 1 study, a randomized, double-blinded, placebo-controlled trial, and the subsequent ADVANCE-CIDP 3 extension study. Analysis involving 122 adults showed a statistically significant difference in relapse rates, with HyQvia outperforming the placebo group in preventing CIDP relapse.