The U.S. Food and Drug Administration (FDA) issued a complete response letter requesting additional information from AstraZeneca regarding the Biologics License Application (BLA) for subcutaneous (SC), self-administration of Saphnelo (anifrolumab). AstraZeneca has submitted the requested information and is working with the FDA to move the application for SC Saphnelo as quickly as possible. A decision on the updated application is expected in the first half of 2026.

In January 2026, AstraZeneca reported positive results from a Phase III TULIP-SC clinical trial, showing a statistically significant and clinically meaningful reduction in disease activity with SC Saphnelo in adults with systemic lupus erythematosus (SLE). The safety profile observed with SC Saphnelo was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion.

In the 52-week study, 56.2% of study participants receiving Saphnelo experienced a significant reduction in lupus disease activity at week 52 compared to 37.1% of participants who received the placebo. Results were measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). In pre-specified secondary and exploratory endpoints, 29.0% of participants taking Saphnelo achieved remission and 40.1% achieved low disease activity by week 52. SC Saphnelo was well tolerated, with the frequency of overall adverse events balanced between the Saphnelo and placebo groups, SC Saphnelo is approved in the European Union and is under regulatory review in other countries, including the United States and Japan.

Continue to follow the Lupus Foundation of America for updates on lupus drug developments. Learn more about Saphnelo.

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