The approval was based on findings from an ADVANCE-CIDP 2 study in which the response rate was observed at 94.4% with 18 respondents along with a change in participants' grip strength and their R-ODS score
Takeda’s global headquarter in Tokyo, Japan. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has received the US Food and Drug Administration (FDA) approval for Gammagard Liquid [Immune Globulin Infusion (Human) 10% solution] to treat adults chronic inflammatory demyelinating polyneuropathy (CIDP).
Gammagard Liquid is an intravenous immunoglobulin (IVIG). It is designed to be infused into the veins.
The US FDA has approved the medication as an IVIG therapy to enhance neuromuscular disability and impairment in CIDP adults.
The approval was based on findings from an ADVANCE-CIDP 2 clinical study that evaluated the efficacy and safety of Gammagard Liquid in CIDP adults who developed a relapse in the ADVANCE-CIDP 1 study that assessed efficacy, safety and tolerability of Hyqvia in adults with CIDP.
ADVANCE-CIDP 2’s efficacy was determined by responder rate, where a person was considered to have improved in terms of functional impairment.
The response rate was observed at 94.4% with 18 respondents. In addition, participants’ grip strength improved, and their Rasch-built Overall Disability Scale (R-ODS) score changed.
Takeda US plasma-derived therapies business unit head and senior vice president Richard Ascroft said: “The approval of Gammagard Liquid for 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 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.”
In a similar development, Takeda received approval from the European Commission (EC) for Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for CIDP.
EC approved Hyqvia as maintenance therapy in patients of all ages with CIDP after stabilisation with intravenous immunoglobulin therapy (IVIG).
The approval was based on results from the Phase 3 ADVANCE-CIDP 1 trial which evaluated the efficacy and safety of the drug.
According to the results, the CIDP relapse rate was shown to be clinically significantly lower with Hyqvia compared to placebo. Additionally, the treatment difference was -16.2, favouring Hyqvia over placebo.
In January this year, the US FDA approved Hyqvia as maintenance therapy for CIDP treatment in the US.