Benralizumab - MedImmune/Kyowa Hakko Kirin

Drug Profile

Benralizumab - MedImmune/Kyowa Hakko Kirin

Alternative Names: Benra; BIW-8405; BIW-8405-IL-5R; Fasenra; KHK 4563; MEDI-563

Latest Information Update: 17 Nov 2017

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At a glance

  • Originator BioWa
  • Developer AstraZeneca; Kyowa Hakko; Kyowa Hakko Kirin; MedImmune; National Jewish Medical and Research Center
  • Class Antiasthmatics; Monoclonal antibodies
  • Mechanism of Action Immunomodulators; Interleukin 5 receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Registered Asthma
  • Phase III Chronic obstructive pulmonary disease
  • Phase II Churg-Strauss syndrome; Hypereosinophilic syndrome; Rhinosinusitis

Most Recent Events

  • 14 Nov 2017 Registered for Asthma (Adjunctive treatment, In adolescents, Treatment-experienced, In adults) in USA (SC) - First global approval
  • 13 Nov 2017 No development reported - Phase-II for Asthma in Russia, Peru, Mexico, Colombia, Brazil, Japan, Bulgaria (SC)
  • 10 Nov 2017 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of benralizumab for Asthma (Treatment-experienced, Adjunctive treatment) in European Union
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