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Alpha-1 antitrypsin - Kamada

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Drug Profile

Alpha-1 antitrypsin - Kamada

Alternative Names: A1AT; A1PI; AAT; AAT-IH; AAT-IV; Alpha-1 Antitrypsin; Alpha-1-Antiproteinase; alpha-1-proteinase inhibitor; ALPHA.1-PROTEINASE INHIBITOR HUMAN; Aralast; D1-AAT; G1-AAT; G1-AAT IV; Glassia; Infinia; Inhaled-AAT; IV AAT; Kamada-API; L1-AAT; Prolastin-C

Latest Information Update: 15 May 2024

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At a glance

  • Originator Kamada
  • Developer Kamada; Mount Sinai Hospital (Toronto); Takeda
  • Class Acute-phase proteins; Alpha globulins; Anti-inflammatories; Antiallergics; Antihyperglycaemics; Blood proteins; Secretory proteinase inhibitory proteins; Serpins
  • Mechanism of Action Immunomodulators; Serine endopeptidase inhibitors
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease; Bronchiectasis; Alpha 1-antitrypsin deficiency; Cystic fibrosis; Type 1 diabetes mellitus
  • New Molecular Entity No

Highest Development Phases

  • Marketed Alpha 1-antitrypsin deficiency
  • Discontinued Bronchiectasis; Cystic fibrosis; Graft-versus-host disease; Lung transplant rejection; Type 1 diabetes mellitus

Most Recent Events

  • 15 May 2024 Kamada anticipates a feedback from the US FDA regarding a revised Statistical Analysis Plan (SAP) and study protocol of the phase III InnovAATe trial, by 2H of 2024
  • 08 May 2024 Kamada submits an IND amendment consisting of a revised Statistical Analysis Plan (SAP) and study protocol of the phase III InnovAATe trial for Alpha 1-antitrypsin deficiency
  • 08 May 2024 The US FDA provides a positive feedback to accept P<0.1 alpha level as a primary endpoint for registration in the phase III InnovAATe trial for Alpha 1-antitrypsin deficiency
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