The US Food and Drug Administration (FDA) has approved Takeda’s GAMMAGARD LIQUID for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
The approval positions GAMMAGARD LIQUID as an intravenous immunoglobulin (IVIG) therapy option for improving neuromuscular disability and impairment in affected individuals.
The approval was granted based on data from 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.
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.
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Pyrexia, headache and haematological changes such as anaemia and leukopenia were among adverse reactions reported in the trial.
With the approval, GAMMAGARD LIQUID became the only IVIG in the US with multiple neuromuscular disorder indications.
It is also approved as a maintenance therapy for multifocal motor neuropathy to boost muscle strength and disability and as a replacement therapy for primary immunodeficiency in individuals aged two years and older.
Takeda US plasma-derived therapies business unit senior vice-president and head Richard Ascroft stated: “The approval of GAMMAGARD LIQUID for the treatment of CIDP 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.
“Together with the recent HYQVIA [immune globulin infusion 10% (human) with recombinant human hyaluronidase] approval in the US, we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”
The latest development follows the recent regulatory approval for HYQVIA as a CIDP maintenance therapy.
