Overview
Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .
Background
Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .
Indication
This drug is an anti-IgE antibody indicated for:
Associated Conditions
- Chronic Idiopathic Urticaria
- Moderate Asthma
- Severe Asthma
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/07/27 | Phase 1 | Completed | |||
2023/06/23 | Phase 4 | Recruiting | |||
2023/03/17 | Phase 3 | Completed | |||
2022/10/03 | Phase 1 | Completed | |||
2022/10/03 | Phase 1 | Completed | |||
2022/07/08 | Phase 1 | Completed | Jemincare | ||
2022/06/21 | N/A | Completed | |||
2022/06/06 | Phase 4 | UNKNOWN | |||
2022/04/18 | Phase 2 | Recruiting | Stephen J. Teach, MD, MPH | ||
2021/12/14 | N/A | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||