FDA approves Gammagard Liquid [Immune Globulin Infusion (Human) 10% solution] to improve neuromuscular disability and impairment in chronic inflammatory demyelinating polyneuropathy (CIDP)

It can be used as induction therapy, which includes an induction dose followed by maintenance doses. For treatment of CIDP, Gammagard Liquid has not been studied in immunoglobulin-naive patients nor as maintenance therapy for periods longer than six months.

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 a prospective, 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 in the randomized, double-blinded, placebo-controlled study evaluating efficacy, safety and tolerability of Hyqvia (ADVANCE-CIDP 1) in adults with CIDP. Efficacy in ADVANCE-CIDP 2 was based on responder rate, where a responder was defined as a subject who demonstrated an improvement of functional disability. The responder rate was 94.4% (N=18, 95% CI: 74.2% to 99.0%). Improvement in grip strength and change in Rasch-built Overall Disability Scale (R-ODS) score were recorded across participants.