Saphnelo anifrolumab-fnia

Drug Class

Type I interferon receptor antagonist

Mechanism

Binds to subunit 1 of the type I interferon receptor (IFNAR1), blocking type I interferon signaling and downregulating interferon-stimulated gene expression.

Approved Indication

Treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

What This Means For Patients

Saphnelo (anifrolumab-fnia) is an intravenous targeted biological therapy approved by the FDA and EMA for patients with moderate to severe systemic lupus erythematosus (SLE). It works by blocking type I interferon signaling, which plays a major role in lupus-related inflammation. Patients can access this medicine for clinical use through special import programs in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2021) — label
• EMA — approved (2022) — source

Pivotal Clinical Evidence

• TULIP-2 — Morand et al., N Engl J Med 2020 (NCT02446899) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761123s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/saphnelo