Skip to main content

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.

Source: Teva Announces FDA Approval of CINQAIR® (reslizumab) Injection
Teva Pharmaceutical Industries Ltd. accessed March 23, 2016

Development timeline for Cinqair

Mar 23, 2016Approval FDA Approves Cinqair (reslizumab) to Treat Severe Asthma
Dec 10, 2015FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.