FDA Approves Anifrolumab for Systemic Lupus Erythematosus in Adults


The first-in-class monoclonal antibody is the first therapeutic expansion for this patient population in over 10 years.


The US Food and Drug Administration (FDA) has approved anifrolumab-fnia (Saphnelo) for the treatment of moderate to severe systemic lupus erythematosus (SLE) in adults. The approval was granted to AstraZeneca.

SLE is the most common form of lupus affecting up to 300,000 individuals in the United States. Patients with the autoimmune condition may experience long-term organ damage and poor health-related quality of life.

The approval of anifrolumab-fnia, a first-in-class type I interferon receptor antagonist, represents the first expansion in treatment options for these patients in over 10 years.

“Today’s landmark approval of SAPHNELO is the culmination of years of AstraZeneca’s pioneering research in the type I interferon pathway, a central driver in systemic lupus erythematosus pathophysiology,” said Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D, in a statement. “This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often-debilitating disease.”

Supporting Data

Approval was based on efficacy and safety data from TULIP-1 and TULIP-2, both phase 3 trials, and the MUSE Phase 2 trial.

All 3 studies showed that treatment with anifrolumab-fnia was associated with reduction in overall disease activity across organ systems. Furthermore, patients demonstrated a sustained reduction in oral corticosteroid use when compared with placebo. Both treatment groups received standard therapy.

Across all trials, the most frequently reported adverse reactions that were reported by patients were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough.

Additional research is assessing the subcutaneous delivery of treatment. Phase 3 trials are also evaluating the use of anifrolumab-fnia in anifrolumab-fnia.

AstraZeneca is seeking further regulatory approval in the European Union and Japan.

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