Benralizumab - Kyowa Hakko Kirin/MedImmune

Drug Profile

Benralizumab - Kyowa Hakko Kirin/MedImmune

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

Latest Information Update: 22 Jun 2018

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At a glance

  • Originator BioWa
  • Developer AstraZeneca; Cincinnati Children's Hospital Medical Center; 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

  • Marketed Asthma
  • Phase III Chronic obstructive pulmonary disease; Nasal polyps
  • Phase II Churg-Strauss syndrome; Hypereosinophilic syndrome; Rhinosinusitis
  • Phase I/II Eosinophilic gastroenteritis

Most Recent Events

  • 22 Jun 2018 AstraZeneca plans the phase III PONENTE trial for Asthma in USA, Argentina, Russia, Colombia and Germany, in July 2018 (NCT03557307)
  • 10 Apr 2018 AstraZeneca and MedImmune complete phase III GALATHEA trial in Chronic obstructive pulmonary disease in US, Canada, the UK, Austria, Czech Republic, Hungary, The Netherlands, Germany, Italy, Poland, Russia, Romania, Spain, South Africa and Switzerland (NCT02138916)
  • 09 Apr 2018 AstraZeneca completes the phase III TERRANOVA trial for Chronic obstructive pulmonary disease in USA, Argentina, Colombia, Peru, Australia, Belgium, Bulgaria, France, Denmark, Sweden, Poland, Norway, Philippines, Taiwan, Vietnam, Turkey, Ukraine, Israel, Croatia, Slovenia, Brazil, Chile, Mexico, New Zealand, Serbia and Thailand (SC) (NCT02155660)
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