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Benralizumab - AstraZeneca/Kyowa Kirin

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: 18 Apr 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; Churg-Strauss syndrome; Eosinophilic gastroenteritis; Eosinophilic oesophagitis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Asthma
  • Preregistration Nasal polyps
  • Phase III Chronic obstructive pulmonary disease; Churg-Strauss syndrome; 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

  • 11 Apr 2024 The US FDA approves benralizumab for Asthma (Adjunctive treatment, In children) (aged 6 to 11) (SC)
  • 26 Feb 2024 Efficacy data from the phase III MANDARA trial in Churg-Strauss syndrome released by AstraZeneca
  • 13 Feb 2024 AstraZeneca completes phase-III clinical trials in Eosinophilic gastroenteritis (In adolescents, In adults, In children) in USA, Vietnam, Ukraine, Mexico, Japan, Italy, France, China, Canada, Brazil, Australia (SC) (NCT05251909)
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