FDA says no to AstraZeneca’s Saphnelo Subcutaneous Formulation for Lupus Patients | iPharmaCenter
- Badari Andukuri
- 4 hours ago
- 2 min read
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for AstraZeneca’s Biologics License Application (BLA) seeking approval of Saphnelo (anifrolumab) for subcutaneous administration in adults with systemic lupus erythematosus (SLE). This is despite Saphnelo SC meeting primary endpoint in clinical trial.
AstraZeneca has provided the additional information requested and stated its commitment to working closely with the FDA to advance the application swiftly. A regulatory decision on the updated submission is expected in the first half of 2026. Meanwhile, the intravenous (IV) formulation of Saphnelo remains commercially available in the U.S.
Background on the Saphnelo SC Application
The original BLA submission was supported by interim data from the Phase III TULIP-SC trial, which evaluated the efficacy and safety of Saphnelo administered subcutaneously. The study met its primary endpoint, and the safety profile of the subcutaneous formulation was consistent with that of the approved IV formulation.
In December 2025, AstraZeneca announced that the European Union approved Saphnelo for subcutaneous self-administration via a pre-filled pen for patients with moderate to severe SLE.
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About the TULIP-SC Trial
TULIP-SC was a Phase III, multicenter, randomized, double-blind, placebo-controlled study assessing subcutaneous anifrolumab in adults aged 18–70 with moderate to severe SLE who were receiving standard therapy such as corticosteroids, antimalarials, or immunosuppressants.
Disease activity reduction was measured using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52, which requires improvement in all affected organs from baseline without new disease flares.
A total of 367 participants were randomized 1:1 to receive either a 120 mg subcutaneous dose of anifrolumab or placebo via a pre-filled, single-use syringe. A planned interim analysis was conducted after the first 220 participants completed week 52. The trial also includes a 52-week open-label extension for participants who completed the initial treatment phase.
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About Saphnelo (anifrolumab)
Saphnelo is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, thereby blocking the activity of type I IFNs—cytokines such as IFN-alpha, IFN-beta, and IFN-kappa that drive inflammation in SLE.