Cinqair FDA Approval History
Cinqair (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with eosinophilic asthma.
The FDA approval of Cinqair was based on efficacy and safety data from five placebo-controlled studies that included 1,028 asthma patients. In the three Phase III studies, Cinqair was associated with reduction in asthma attacks of up to 59% as well as a significant improvement in lung function, symptoms, and asthma-related quality of life.
Cinqair is administered via intravenous infusion every four weeks in a clinical setting prepared to manage anaphylaxic reactions. The most common side effect reported during clinical trials was oropharyngeal pain.
Teva Pharmaceutical Industries Ltd. accessed March 23, 2016
Development timeline for Cinqair
|Mar 23, 2016||Approval FDA Approves Cinqair (reslizumab) to Treat Severe Asthma|
|Dec 10, 2015||FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab|
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