Saphnelo

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE) despite standard therapy. The marketing authorization application was submitted on 8 October 2020, and a positive CHMP opinion was issued on 16 December 2021. The drug has a shelf life of 36 months.

Anifrolumab demonstrated an average KD on human PBMCs of 0.29 nM, with 1448 IFNAR1 sites detected. Its IC50 for IFN-α2 ranged from 0.149 nM (100 U) to 9.748 nM (100,000 U). For CpG-A stimulated pDC media, IC50 values ranged from 0.021 nM (1/1000 dilution) to 0.721 nM (1/10 dilution). For DNA-IC stimulated pDC media, IC50 values ranged from 0.060 nM (1/1000 dilution) to 0.214 nM (1/10 dilution).

In cynomolgus monkeys, the mean CL for IV doses ranged from 2.58 mL/kg/d (100 mg/kg) to 140 mL/kg/d (0.03 mg/kg). The terminal half-life for SC administration was 13.2 days, and for IV administration, it was 8.42 days. The median Tmax after a single SC administration of 5 mg/kg anifrolumab was 2 days.