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Immune globulin kthm - Kedrion Biopharma

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Drug Profile

Immune globulin kthm - Kedrion Biopharma

Alternative Names: 10% IVIG therapy - Kedrion Biopharma; Immune globulin IV, human-kthm 10% solution - Kedrion Biopharma; Kedrion IVIG 10%; KIg-10; QIVIGY

Latest Information Update: 24 Dec 2025

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At a glance

  • Originator Kedrion Biopharma
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Antidementias; Antifibrotics; Antivirals; Eye disorder therapies; Immunoglobulins; Immunoproteins; Polyethylene glycols; Serum globulins; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered Primary immunodeficiency diseases
  • Phase III Idiopathic thrombocytopenic purpura

Most Recent Events

  • 06 Oct 2025 Registered for Primary immunodeficiency diseases in USA (IV)
  • 29 Sep 2025 Kedrion Biopharma plans to launch immune globulin kthm in the US for the treatment of immunodeficiency disorders in early 2026 with plans for global expansion in Europe and other markets upon approval
  • 29 Sep 2025 Efficacy and adverse events data from the phase III CARES10 trial in Primary immunodeficiency diseases released by Kedrion Biopharma

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