Overview
Anakinra is a recombinant human interleukin-1 (IL-1) receptor antagonist (IL-1Ra) composed of 153 amino acid residues. Unlike native human IL-1Ra, anakinra has an additional methionine residue at the amino terminus. This drug binds to the IL-1 receptor, competing with and inhibiting the activity of IL-1 alpha and beta. Anakinra is indicated for the management of rheumatoid arthritis (RA) in patients 18 years of age or older who have failed one or more disease-modifying antirheumatic drugs (DMARDs), as well as the treatment of neonatal-onset multisystem inflammatory disease (NOMID) and deficiency of interleukin-1 receptor antagonist (DIRA). Since IL-1 has an important role in inflammation and immunological responses, anakinra is also used for the off-label treatment of inflammatory diseases. Anakinra is produced using the E. Coli bacterial expression system. On November 14, 2001, it was approved by the FDA for the treatment of rheumatoid arthritis. It was later approved for the treatment of NOMID and DIRA on December 21, 2012, and December 18, 2020, respectively. A few studies have evaluated the use of anakinra for the treatment of coronavirus disease 2019 (COVID-19). On November 8, 2022, the FDA issued an emergency use authorization (EUA) of anakinra for the treatment of COVID-19 in hospitalized patients who are at risk of progressing to severe respiratory failure.
Indication
Anakinra is an interleukin-1 receptor antagonist indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed one or more disease-modifying antirheumatic drugs (DMARDs). Anakinra can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents. Anakinra is also indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) and the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). Anakinra is also used off-label for the treatment of several inflammatory diseases. The FDA has issued an emergency use authorization (EUA) for the emergency use of anakinra for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Since anakinra is approved for this condition under EUA, the drug should only be used when there are no alternative treatment available.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
- Cryopyrin-associated Periodic Syndromes (CAPS)
- Deficiency of the interleukin-1 receptor antagonist
- Idiopathic Recurrent Pericarditis
- Moderately to Severely Active Rheumatoid Arthritis
- Neonatal-Onset Multisystem Inflammatory Disease (NOMID)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/29 | Phase 2 | Recruiting | |||
2024/11/25 | Phase 1 | Not yet recruiting | |||
2024/11/20 | Phase 4 | Not yet recruiting | Meyer Children's Hospital IRCCS | ||
2024/10/30 | Phase 4 | Not yet recruiting | |||
2024/10/03 | Phase 4 | Recruiting | |||
2024/04/24 | Phase 3 | Not yet recruiting | |||
2024/03/29 | Phase 3 | Recruiting | |||
2023/10/06 | Not Applicable | Recruiting | Azienda Ospedaliero, Universitaria Ospedali Riuniti | ||
2023/10/02 | Phase 1 | Recruiting | |||
2023/07/03 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Swedish Orphan Biovitrum AB (publ) | 66658-234 | SUBCUTANEOUS | 100 mg in 0.67 mL | 12/30/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/8/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Anakinra injection | 国药准字SJ20230016 | 生物制品 | 注射剂 | 10/27/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KINERET anakinra 100mg/0.67mL solution for injection prefilled syringe | 82872 | Medicine | A | 6/17/2003 |
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