Takeda received approval from the U.S. FDA for GAMMAGARD LIQUID [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It can be used as induction therapy, which includes an induction dose followed by maintenance doses. 

This milestone follows the recent FDA approval of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults with CIDP. HYQVIA is the only combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous IG infusion.

The approval is based on results from an open-label, single-arm, multicenter clinical study (ADVANCE-CIDP 2) that evaluated the efficacy and safety of GAMMAGARD LIQUID in adults with CIDP who developed a relapse. Efficacy in the study was based on responder rate, defined as a subject who demonstrated an improvement of functional disability. The responder rate was 94%. Improvement in grip strength and change in Rasch-built Overall Disability Scale (R-ODS) score were recorded across participants.

CIDP is a rare, acquired, immune-mediated neuromuscular disorder affecting the peripheral nervous system. It’s characterized by progressive, symmetric symptoms such as weakness, tingling or loss of feeling in distal and proximal limbs, loss of reflexes and difficulty walking. The mechanism of action of immunoglobulins in the treatment of CIDP in adults has not been fully elucidated but may include immunomodulatory effects.