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Immune globulin - Grifols

Drug Profile

Immune globulin - Grifols

Alternative Names: Flebogamma 10% DIF; Flebogamma 5% DIF; Flebogamma DIF; GamaSTAN; GamaSTAN S/D; Human normal immunoglobulin; IGSC 20% - Grifols; Immune Globulin Subcutaneous 20% Caprylate/Chromatography; Intravenous normal Human immunoglobulin – Grifols; IVIG - Grifols; Xembify; Xepol; XS-28

Latest Information Update: 05 May 2020

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At a glance

  • Originator Grifols
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; Serum globulins; Skin disorder therapies; Vascular disorder therapies
  • 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 - Postpoliomyelitis syndrome
  • New Molecular Entity No

Highest Development Phases

  • Marketed Guillain-Barre syndrome; Hepatitis A; Idiopathic thrombocytopenic purpura; Immunodeficiency disorders; Measles; Rubella; Varicella zoster virus infections
  • Registered Mucocutaneous lymph node syndrome
  • Preregistration Chronic inflammatory demyelinating polyradiculoneuropathy; Motor neuron disease
  • Phase II/III Alzheimer's disease; Postpoliomyelitis syndrome

Most Recent Events

  • 10 Apr 2020 Grifols Therapeutics terminates a planned phase III trial for Immunodeficiency disorders (In children, In adolescents, In adults, In elderly, Treatment naive, Treatment experienced) in USA and European Union due to the regulatory approval of the product in this indication (IV, SC) (NCT03814798)
  • 13 Mar 2020 Pharmacokinetics and adverse events data from a phase III trial in Immunodeficiency disorders presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAI-2020)
  • 13 Mar 2020 Adverse events data from a phase III trial for Immunodeficiency disorders presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020)
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