FDA approves IV immunoglobulin therapy for CIDP in adults

Key takeaways:

• Gammagard Liquid is an immune globulin infusion (human) 10% solution.
• It is the only IV-based immunoglobulin therapy with multiple neuromuscular indications in the U.S.

The FDA has approved Gammagard Liquid as an IV immunoglobulin therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.

According to a release from Takeda, approval for Gammagard Liquid (immune globulin infusion [human] 10% solution) was based on results from ADVANCE-CIDP 2, a prospective, open-label, single-arm, multicenter clinical study that evaluated safety and efficacy in adults with CIDP who developed a relapse in the ADVANCE-CIDP 1 study, a randomized, double-blind, placebo-controlled study evaluating safety, efficacy and tolerability of Hyqvia (immune globulin infusion [human] 10% solution with recombinant human hyaluronidase).

Efficacy in ADVANCE-CIDP 2 was based on responder rate (94.4% [n =18; 95% CI, 74.2%- 99%]), defined as participants who showed improved functional disability, including grip strength improvements and change in Rasch-built Overall Disability Scale score, per the release.

With this approval, Gammagard Liquid is the only IV-based immunoglobulin therapy with multiple neuromuscular disorder indications in the United States, as well as being the only FDA-approved IVIG to treat multifocal motor neuropathy as a maintenance therapy.

“The approval of Gammagard Liquid for treatment of [chronic inflammatory demyelinating polyneuropathy] is an encouraging validation of our decades-long commitment to advancing plasma-derived therapies on behalf of people living with rare neuromuscular disorders and bringing our portfolio of differentiated IG therapies to these patients,” Richard Ascroft, senior VP and head of Takeda’s U.S. Plasma-Derived Therapies Business Unit, said in the release.