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Research Report
Comprehensive Report on AD-221 (Atorvastatin 5mg/Ezetimibe 10mg Fixed-Dose Combination)
1. Executive Summary
AD-221, a fixed-dose combination (FDC) of atorvastatin 5mg and ezetimibe 10mg, has emerged as a significant therapeutic option for primary hypercholesterolemia. Developed by Addpharma Co., Ltd. and marketed in South Korea as Atovamibe Tab. 10/5mg by Yuhan Corporation, this FDC leverages the complementary mechanisms of HMG-CoA reductase inhibition by atorvastatin and cholesterol absorption inhibition by ezetimibe. Clinical development, primarily through the Phase 3 trial NCT05131997, has demonstrated that AD-221 achieves superior low-density lipoprotein cholesterol (LDL-C) reduction (approximately 49%) compared to monotherapies with atorvastatin 5mg, ezetimibe 10mg, and even moderate-intensity atorvastatin 10mg. This enhanced efficacy allows a greater proportion of patients to achieve stringent lipid targets. Pharmacokinetic studies indicate that the FDC provides overall systemic exposure comparable to the co-administration of its individual components, despite some variations in peak concentrations for ezetimibe. The safety and tolerability profile of AD-221 is favorable, characterized by a low incidence of adverse events and, notably, no reported cases of myopathy or rhabdomyolysis in its pivotal Phase 3 study. Evidence also suggests a potentially better safety profile, including fewer liver enzyme elevations, compared to moderate-intensity atorvastatin monotherapy. Approved by the South Korean Ministry of Food and Drug Safety in May 2023, AD-221 (Atovamibe) is positioned as a valuable treatment for patients requiring substantial LDL-C lowering, particularly those who may benefit from a lower statin dose to enhance tolerability or for whom moderate-intensity statin monotherapy is insufficient.
2. Introduction
2.1. Context of Hypercholesterolemia and Lipid-Lowering Therapies
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2022/01/21 | Phase 1 | Completed | |||
2021/11/23 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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