FDA Approved Saphnelo™ (Anifrolumab-fnia) as a New Treatment for Lupus

The U.S. Food and Drug Administration (FDA) has approved Saphnelo™ (anifrolumab-fnia) as a treatment for adults with systemic lupus erythematosus (SLE) who are receiving standard therapy. It is the third U.S. FDA approval of a lupus therapy since 2011, expanding treatment options for this medically underserved and life-threatening autoimmune disease.

Saphnelo inhibits a key protein in the immune system called the IFNAR receptor that acts as a transmitter, amplifying signals from tiny messengers called type I interferons. This process activates many parts of the immune system and can trigger major inflammation. Saphnelo dampens the excessive type I interferon signature found in up to 80% of adults with lupus and as many as 90% of children with the disease.

Anifrolumab-fnia blocks type I interferons, a main factor that leads to tissue damage and symptom severity in patients with SLE. Approximately 60 to 80 percent of adults have high levels of this interferon.

The Phase 3 clinical trials, TULIP-1 and TULIP-2, have proven the safety and efficacy of anifrolumab-fnia for treating SLE. Results indicated the drug reduced flares and allowed for lowered steroid use. Additionally, patients receiving anifrolumab-fnia had reductions in arthritis symptoms and severity of skin rash.