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

AdARRC™ August 9, 2021 Monday Weekly Update
FDA Approved Saphnelo™ (Anifrolumab-fnia) as a New Treatment for Lupus

The Drug

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.

Conclusion

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

Reference

Recent studies, such as those funded by the Lupus Research Alliance (LRA), have played a pivotal role in analyzing the molecules’ role in treating patients with SLE.

“The role of interferon in lupus has been supported by the science for years but has long awaited this formal proof of benefit in a clinical trial,” stated Eric Morand, MD, PhD, an LRA Distinguished Innovator Award recipient. “The FDA approval of anifrolumab-fnia potentially allows thousands of lupus patients to benefit. Decreased disease activity along with reduced steroid use form the pillars of treatment goals in lupus, and anifrolumab-fnia has shown these effects. As an LRA investigator, I am extremely proud to have been involved in this landmark in the journey to improve the lives of people with lupus.”

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