Saphnelo (anifrolumab-fnia) BLA 761451 Approved April 24 2026
Summary
AstraZeneca AB received FDA approval on April 24, 2026 for Saphnelo (anifrolumab-fnia), a biologic drug product, under BLA 761451. The approved formulations include a 300MG/2ML (150MG/ML) single-use vial and a 120MG/0.8ML injection, both for prescription use only. The approval letter and supporting documentation are available through the FDA Drugs@FDA portal.
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GovPing monitors FDA Drugs@FDA - New Applications and Actions for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 17 changes logged to date.
What changed
The FDA granted approval for AstraZeneca AB's Saphnelo (anifrolumab-fnia) biologic license application 761451, authorizing marketing of the drug in two dosage forms: a 300MG/2ML (150MG/ML) single-use vial and a 120MG/0.8ML injection. The approval is classified as an original approval with no assigned therapeutic equivalence code, no reference listed drug status, and no orphan drug designation.
Pharmaceutical companies with biologics in development should note this FDA approval pathway milestone for a novel biologic agent. Healthcare providers prescribing biologic medications should review the approved labeling once available through FDA resources. The absence of orphan drug designation and standard review priority indicates this approval followed the standard biologic licensing review process.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
*Home | *
Biologic License Application (BLA): 761451
Company: ASTRAZENECA AB
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| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SAPHNELO | ANIFROLIMAB-FNIA | 300MG/2ML (150MG/ML | VIAL; SINGLE-USE | Prescription | None | No | No |
| SAPHNELO | ANIFROLIMAB-FNIA | 120MG/0.8ML | INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/24/2026 | ORIG-1 | Approval | N/A | Letter (PDF) | Label is not available on this site. | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761451Orig1s000ltr.pdf |
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