Treats moderate to severe systemic lupus erythematosus (SLE). BLA 761451, held by Astrazeneca AB. Anifrolumab-Fnia.
As of Nov 13, 2026, BLA 761451 (Saphnelo), held by Astrazeneca AB, was first approved by FDA on Apr 24, 2026, with 0 approved supplements and 1 published complete response letter.
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 10, 2025 | Anifrolumab | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Saphnelo300MG/2ML (150MG/ML · vial; single-use | Anifrolumab-Fnia | Rx |
| Saphnelo120MG/0.8ML · injection | Anifrolumab-Fnia | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
