An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Trial Profile

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Discontinued
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2016

At a glance

  • Drugs Reslizumab (Primary)
  • Indications Asthma; Eosinophilia
  • Focus Adverse reactions
  • Sponsors Cephalon; Teva Branded Pharmaceutical Products R&D
  • Most Recent Events

    • 18 Aug 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700193046, 700194103, 700194191 & 700212125) the European Commission has granted marketing authorization for reslizumab for the treatment of asthma.
    • 24 Jun 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700193046, 700194103, 700194191 & 700212125) the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization of reslizumab for the treatment of severe eosinophilic asthma. The final decision by the European Commission is expected in the second half of 2016.
    • 23 Mar 2016 According to a Teva Pharmaceuticals media release, based on the data from five placebo-controlled studies the U.S. Food and Drug Administration (FDA) has approved CINQAIR (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
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