CINQAIR
CINQAIR (reslizumab) is an interleukin-5 antagonist monoclonal antibody indicated for the add-on maintenance treatment of severe asthma. It is specifically approved for adult patients aged 18 years and older who present with an eosinophilic phenotype. The medication is not intended for the treatment of other eosinophilic conditions or for the relief of acute respiratory symptoms such as bronchosp
Details
- Status
- Prescription
- First Approved
- 2016-03-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CINQAIR Approval History
What CINQAIR Treats
1 indicationsCINQAIR is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
CINQAIR Boxed Warning
ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experience...
WARNING: ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis occurred with CINQAIR infusion in 0.3% of patients in placebo-controlled studies ( 5.1 ) Patients should be observed for an appropriate period of time after CINQAIR infusion; healthcare professionals should be prepared to manage anaphylaxis that can be life-threatening ( 5.1 ) Discontinue CINQAIR immediately if the patient experiences anaphylaxis ( 5.1 )
CINQAIR Competitors
Pro2 other drugs also target IL-5. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-5). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CINQAIR FDA Label Details
ProIndications & Usage
FDA Label (PDF)CINQAIR ® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies ] . Limitation of Use: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ] . CINQAIR is 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 . Limitation...
WARNING: ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening. ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.