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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2021) — Sources
• EMA — Approved (2022) — Sources

Pivotal Clinical Evidence

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

Sources

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