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Benralizumab - AstraZeneca/Kyowa Kirin

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Drug Profile

Benralizumab - AstraZeneca/Kyowa Kirin

Alternative Names: Benra; Benralizumab - AstraZeneca/Kyowa Hakko Kirin; Benralizumab - Kyowa-Hakko/AstraZeneca; BIW-8405; BIW-8405-IL-5R; Fasenra; KHK-4563; MEDI-563

Latest Information Update: 27 Sep 2024

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At a glance

  • Originator BioWa
  • Developer AstraZeneca; Kyowa Hakko; Kyowa Kirin; McMaster University; MedImmune; National Jewish Medical and Research Center
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antibronchitics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Apoptosis stimulants
  • Orphan Drug Status

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

    Yes - Hypereosinophilic syndrome; Eosinophilic gastroenteritis; Eosinophilic oesophagitis; Churg-Strauss syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Asthma
  • Registered Churg-Strauss syndrome
  • Preregistration Nasal polyps
  • Phase III Chronic obstructive pulmonary disease; Hypereosinophilic syndrome
  • Phase II Atopic dermatitis; Rhinosinusitis
  • No development reported Skin disorders
  • Discontinued Bronchiectasis; Bullous pemphigoid; Chronic urticaria; Eosinophilic gastroenteritis; Eosinophilic oesophagitis

Most Recent Events

  • 27 Sep 2024 Preregistration for Churg-Strauss syndrome (Treatment-resistant) in European Union (SC)
  • 24 Sep 2024 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of benralizumab for Churg-Strauss syndrome (Treatment-resistant) in European Union
  • 19 Sep 2024 Registered for Churg-Strauss syndrome (Treatment-resistant) in USA (SC)

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