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SAPHNELO (ANIFROLUMAB-FNIA)
SAPHNELO (generic name: ANIFROLUMAB-FNIA) is a Type I Interferon Receptor Antagonist [EPC] drug developed by ASTRAZENECA AB. It is currently FDA-approved for Moderate to severe systemic lupus erythematosus (SLE).
Anifrolumab is an antibody that targets the interferon-alpha/beta receptor alpha chain, classified as an antagonist. It is being studied in clinical trials for conditions such as Systemic Lupus Erythematosus, Interstitial Lung Disease, and Sjogren's Syndrome.
At a glance
| Generic name | ANIFROLUMAB-FNIA |
|---|---|
| Sponsor | ASTRAZENECA AB |
| Drug class | Type I Interferon Receptor Antagonist [EPC] |
| Target | Interferon alpha/beta receptor 1 |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
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
Serious adverse events
- Serious infections
- Pneumonia
- Fatal infections
- COVID-19
Key clinical trials
- Saphnelo for Intravenous Infusion 300 mg Specific Use Result Study All Patient Investigation in Patients With Systemic Lupus Erythematosus (N/A)
- A Randomized, Positvel Controlled, Multicenter Study of Effects of Telitacicept vs Cyclophosphamide on Lupus Realted Interstitial Lung Disease (Phase 4)
- Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study (N/A)
- A Randomized, Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Chinese Participant (Phase 1)
- PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab (N/A)
- DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosu (N/A)
- A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrol (N/A)
- AZAHAR Study. Observational Retrospective Study To Describe Characteristics And Clinical Outcomes of Patients With Systemic Lupus Erythematosus Initiating Saphnelo (Anifrolumab) in a Real-World Settin (N/A)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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 AB portfolio CI
Frequently asked questions about SAPHNELO
What is SAPHNELO?
SAPHNELO (ANIFROLUMAB-FNIA) is a Type I Interferon Receptor Antagonist [EPC] drug developed by ASTRAZENECA AB, indicated for Moderate to severe systemic lupus erythematosus (SLE).
What is SAPHNELO used for?
SAPHNELO is indicated for Moderate to severe systemic lupus erythematosus (SLE).
Who makes SAPHNELO?
SAPHNELO is developed and marketed by ASTRAZENECA AB (see full ASTRAZENECA AB pipeline at /company/astrazeneca).
What is the generic name of SAPHNELO?
ANIFROLUMAB-FNIA is the generic (nonproprietary) name of SAPHNELO.
What drug class is SAPHNELO in?
SAPHNELO belongs to the Type I Interferon Receptor Antagonist [EPC] class. See all Type I Interferon Receptor Antagonist [EPC] drugs at /class/type-i-interferon-receptor-antagonist-epc.
What development phase is SAPHNELO in?
SAPHNELO is FDA-approved (marketed).
What are the side effects of SAPHNELO?
Common side effects of SAPHNELO include Upper respiratory tract infection, Bronchitis, Infusion-related reactions, Herpes Zoster, Cough, Respiratory tract infection. Serious adverse events: Serious infections, Pneumonia, Fatal infections, COVID-19.
What does SAPHNELO target?
SAPHNELO targets Interferon alpha/beta receptor 1 and is a Type I Interferon Receptor Antagonist [EPC].
Related
- Drug class: All Type I Interferon Receptor Antagonist [EPC] drugs
- Target: All drugs targeting Interferon alpha/beta receptor 1
- Manufacturer: ASTRAZENECA AB — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Moderate to severe systemic lupus erythematosus (SLE)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing