Cinqair FDA Approval History
FDA Approved: Yes (First approved March 23, 2016)
Brand name: Cinqair
Generic name: reslizumab
Dosage form: Injection
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Asthma
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.
http://www.tevapharm.com/news/teva_announces_fda_approval_of_cinqair_reslizumab_injection_03_16.aspx
Teva Pharmaceutical Industries Ltd. accessed March 23, 2016
Development timeline for Cinqair
| Date | Article |
|---|---|
| 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 |
Further information
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