Immune globulin - Baxalta

Drug Profile

Immune globulin - Baxalta

Alternative Names: 10% HyQ; 20% SubQ; CuvitruTM; Gammagard Liquid; Gammagard S/D; HyQ; HyQvia; IGIV - Baxalta; IGSC - Baxalta; immune globulin intravenous; IVIG 10%; Kiovig

Latest Information Update: 29 Nov 2016

Price : $50

At a glance

  • Originator Baxter International
  • Developer Baxter International; Halozyme Therapeutics; Shire
  • Class Immunoglobulins; Immunoproteins; Serum globulins
  • Mechanism of Action Amyloid beta-protein inhibitors; Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Chronic inflammatory demyelinating polyradiculoneuropathy; Peripheral nervous system diseases
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Allotransplant rejection; Chronic lymphocytic leukaemia; Guillain-Barre syndrome; HIV infections; Immune thrombocytopenic purpura; Immunodeficiency disorders; Peripheral nervous system diseases
  • Phase III Chronic inflammatory demyelinating polyradiculoneuropathy
  • Phase II Ataxia
  • Suspended Alzheimer's disease

Most Recent Events

  • 16 Nov 2016 Launched for Immunodeficiency disorders (In adolescents, In children, In infants, In adults) in USA (SC)
  • 16 Nov 2016 Updated adverse events data from a phase II/III study of SC immune globulin product (20%) in Primary Immunodeficiency released by Shire
  • 12 Nov 2016 Tolerability data from a North American phase II/III trial in primary immunodeficiency disease released by Shire
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