08/02/2021
💜Your donations helped pay for the research that gave us this new treatment for Lupus! Thank you to everyone who has donated and raised money for the Lupus Research Alliance. 💜
The FDA has approved Saphnelo (Anifrolumab-fnia), a type I interferon receptor antagonist, as a new treatment for people with moderate to severe Systemic Lupus Erythematosus (SLE).
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.
Dr. George Tsokos, Professor of Medicine, Harvard Medical School, Chief, Division of Rheumatology and Clinical Immunology, Beth Israel Deaconess Medical Center, noted that Saphnelo is the first Lupus therapy designed to inhibit type I interferons. “We have known since the 1970’s that interferons were involved with Lupus. With the approval of Saphnelo, we now have one more drug that allows us to translate valuable research knowledge into clinical practice with multiple benefits for our patients with Lupus."
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.
Combined data from two large-scale phase III clinical trials showed that more patients who received Saphnelo, in addition to standard therapy, had improvement than those who received placebo in addition to standard therapy. Saphnelo showed benefits on overall Lupus disease activity, skin Lupus and joints and the ability to taper down steroid doses.
