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Saphnelo (ANIFROLUMAB)
Saphnelo blocks the action of interferon alpha/beta, a protein that triggers an immune response.
At a glance
| Generic name | ANIFROLUMAB |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Type I Interferon Receptor Antagonist [EPC] |
| Target | Interferon alpha/beta receptor 1 |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 700 |
Mechanism of action
Anifrolumab-fnia is human IgG1 monoclonal antibody that binds to subunit of the type interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type IFN signaling, thereby blocking the biologic activity of type IFNs. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets.Type IFNs play role in the pathogenesis of SLE. Approximately 60-80% of adult patients with active SLE express elevated levels of type IFN inducible genes.
Approved indications
- Moderate to severe systemic lupus erythematosus (SLE)
Common side effects
- Upper respiratory tract infection
- Bronchitis
- Infusion-related reactions
- Herpes Zoster
- Cough
- Respiratory tract infection
- Hypersensitivity
- Pneumonia
- Angioedema
- Anaphylaxis
- Fatigue
- Headache
Key clinical trials
- Anifrolumab Malignancy and Serious Infections Study
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (PHASE3)
- A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis) (PHASE3)
- The Anifrolumab PRIM Program
- Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
- Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) (PHASE3)
- Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
- A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Saphnelo CI brief — competitive landscape report
- Saphnelo updates RSS · CI watch RSS
- AstraZeneca portfolio CI