AFREZZA
AFREZZA is a rapid-acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. It serves as a therapeutic option for managing blood sugar levels, though it is not recommended for the treatment of diabetic ketoacidosis. Use of this medication is also not recommended in patients who smoke or who have recently stopped smoking.
How AFREZZA Works
This medication lowers blood glucose levels by stimulating peripheral glucose uptake in skeletal muscle and fat and by inhibiting hepatic glucose production. It further regulates metabolism by inhibiting lipolysis in adipocytes and inhibiting proteolysis. Additionally, the insulin enhances protein synthesis to assist in glycemic management.
Details
- Status
- Prescription
- First Approved
- 2014-06-27
- Routes
- INHALATION
- Dosage Forms
- POWDER
AFREZZA Approval History
What AFREZZA Treats
1 indicationsAFREZZA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
AFREZZA Boxed Warning
RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications ( 4 )]. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all...
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications ( 4 )]. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE See full prescribing information for complete boxed warning. Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD). ( 5.1 ) AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. ( 4 ) Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients. ( 2.5 ), ( 5.1 )
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Active Pipeline
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Key Completed Trials
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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.
AFREZZA FDA Label Details
ProIndications & Usage
FDA Label (PDF)AFREZZA ® is indicated to improve glycemic control in adult patients with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis (DKA) Not recommended in patients who smoke or who have recently stopped smoking Limitations of Use: AFREZZA is not recommended for the treatment of diabetic ketoacidosis (DKA) [see Warning and Precautions ] . The safety and effectiveness of AFREZZA in patients who smoke have not been established...
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung dis...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.