FDA approves Takeda’s GAMMAGARD LIQUID to treat CIDP

30 Jan 2024
www.pharmaceutical-technology.com
Drug ApprovalImmunotherapyClinical Result
The FDA granted the approval based on data from Takeda’s ADVANCE-CIDP 2 clinical trial of GAMMAGARD LIQUID. Credit: Jonathan Weiss / Shutterstock.com.
The FDAFood and Drug Administration (FDA) has apTakeda Takeda’s GAMMAGARD LIQUID for the tGAMMAGARDof adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
The approval was granteGAMMAGARD LIQUIDfrom the open-label, multicentre, single-arm ADVANCE-CIDP 2 clinical trial which evaluated the efficacy and safety of GAMMAGARD LIQUID for adult patients.
Participants received an induction dose of 2g per kilogram of body weight, followed by maintenance doses every three weeks for a six-month period.GAMMAGARD
The study reported a 94.4% responder rate, indicating a significant improvement in functional disability among the subjects.
Participants demonstrated improvements in grip strength and Rasch-built Overall Disability Scale score change.
Pyrexia, headache and haematological changes such as anaemia and leukopenia were among adverse reactions reported in the trial.
Pyrexiae headache, GAMMAGARD LIQUID became the only Ianaemiathe Uleukopeniatiple neuromuscular disorder indications.
It is also approvedGAMMAGARDntenance therapy for mulIVIGcal motor neuropathy to bneuromuscular disordernd disability and as a replacement therapy for primary immunodeficiency in individuals aged two years and older.
Takeda US plasma-derived therapies business unit multifocal motor neuropathyead Richard Ascroft stated: “The approval of GAMMAGARD LIQUID for the treaprimary immunodeficiencyuraging 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.
“Together with the recent HYQVIA [immune globulin infusion 10% (human) with recombinant human hyaluronidase] approval in GAMMAGARD LIQUIDow offer induction andCIDPntenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”neuromuscular disorders
The latest development folHYQVIAheimmune globulinory approval for HYQVIA as recombinant human hyaluronidaseCIDP
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