Trial Profile
A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 01 Feb 2024
Price :
$35
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At a glance
- Drugs Immune globulin (Primary) ; Immune globulin (Primary)
- Indications Chronic inflammatory demyelinating polyradiculoneuropathy
- Focus Registrational; Therapeutic Use
- Acronyms ADVANCE-1; ADVANCE-CIDP 1
- Sponsors Baxalta; Shire; Takeda
- 29 Jan 2024 Results published in a Takeda media release.
- 29 Jan 2024 According to a Takeda media release, company today announced that European Commission (EC) approved HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
- 16 Jan 2024 According to a Takeda media release, based on results from ADVANCE-CIDP 1 and ADVANCE-CIDP 3 trials U.S. Food and Drug Administration (FDA) has approved HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.