A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

Trial Profile

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2017

At a glance

  • Drugs Benralizumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms CALIMA
  • Sponsors AstraZeneca
  • Most Recent Events

    • 14 Nov 2017 According to an AstraZeneca media release, US Food and Drug Administration (FDA) has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
    • 10 Nov 2017 The positive opinion from the CHMP will now be reviewed by the European Commission, as reported in a MedImmune media release.
    • 10 Nov 2017 Based on the data from the WINDWARD programme including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and Phase III oral corticosteroid (OCS)-sparing trial, ZONDA, the CHMP of the EMA has adopted a positive opinion, recommending the marketing authorisation of benralizumab as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting b-agonists.
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