The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to AstraZeneca regarding the Biologics License Application (BLA) for subcutaneous (SC) anifrolumab in the treatment of systemic lupus erythematosus (SLE).
While the Company did not disclose the details of what was requested in the CRL, it was noted that the information required to move the application forward had already been provided to the FDA. A decision on the updated application is now expected in the first half of 2026.
The original BLA submission includes data from the TULIP-SC study (ClinicalTrials.gov Identifier: NCT04877691), which assessed the safety and efficacy of an SC treatment regimen of anifrolumab vs placebo in patients with moderately to severely active, autoantibody-positive SLE despite receiving standard of care treatment.
The trial included patients aged 18 to 70 years who were taking 1 or any combination of the following: oral corticosteroids, antimalarial, and/or immunosuppressants. Study participants (N=367) were randomly assigned 1:1 to receive anifrolumab 120mg SC (n=184) or placebo (n=183) once weekly using a prefilled syringe.
The primary endpoint was a reduction in disease activity as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52. Patients were considered BICLA responders if they had improvement in all organs with disease activity and had no new flares.
Findings at week 52 showed 56.2% of patients treated with anifrolumab SC achieved a statistically significant and clinically meaningful reduction in disease activity compared with 37.1% of placebo patients (treatment difference, 19.1% [95% CI, 9.0-29.2]; P =.0002). Significant improvements in key secondary endpoints were also observed.
Anifrolumab, a type I interferon receptor antagonist, is currently approved under the brand name Saphnelo® for intravenous administration in the treatment of moderate to severe SLE. If approved, a subcutaneous formulation of Saphnelo would allow patients the ability to self-administer the medication outside of a hospital or clinic setting.
This article originally appeared on MPR
References:
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus. News release. AstraZeneca. February 3, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/update-on-saphnelo-subcutaneous-administration.html.
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