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SaphneloTM (anifrolumab-fina) has just been approved by the U.S Food and Drug Administration (FDA) as a treatment for adults with systemic lupus erythematosus (SLE). This treatment is for adults who are receiving standard therapy. It is the third U.S. FDA-approved drug, since 2011, used to treat lupus.

“After having only one therapy approved for lupus during the past 60 years, it is a cause for celebration to have two new treatment options approved in 2021 alone for this life-threatening autoimmune disease that affects an estimated 1.5 million Americans,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America.

Dr. George Tsokos said 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.” Dr. George Tsokos is a member of the Lupus Foundation of America Medical-Scientific Advisory Council, Professor of Medicine at Harvard Medical School, and much more.

Saphnelo inhibits a key protein in the immune system called the IFNAR receptor that acts as a transmitter. It amplifies signals from tiny messengers called type I interfer-

ons. 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.

“The approval of Saphnelo is the culmination of years of clinical development,” said Susan M. Manzi, MD, MPH, Lupus Foundation of America Board Chair and Medical Director and Chair. “Arriving at this important treatment milestone required the involvement of hundreds of people with lupus from around the world, who volunteered to participate in multiple clinical trials. We are grateful for their unselfish efforts, as well as those of basic and clinical physician-scientists who work tirelessly to support lupus drug development. Without them, we could not bring new life-changing therapies to those who need them.”

AstraZeneca developed Saphnelo. It is a monoclonal antibody administered by intravenous (IV ) infusion. The FDA approved Saphnelo for use in treating adults with moderate to severe SLE who are receiving standard therapy.

Original article: https://www.lupusgreaterohio.org/lupus-foundation-of-america-celebrates-fda-approval-of-saphnelo-anifrolumab-fnia-as-a-new-treatment-for-lupus/?fbclid=IwAR2f39AOHCFe7qTsiKSMlDM6Bb52HNGAZadJreKcju6Dm4W73X89Ankhp9o

“Lupus Foundation of America Celebrates FDA Approval of SAPHNELOTM (Anifrolumab-Fnia) as a New Treatment for Lupus.” Lupus Foundation, Ohio, 2 Aug. 2021, www.lupusgreaterohio.org/lupus-foundation-of-america-celebrates-fda-approval-of-saphnelo-anifrolumab-fnia-as-a-new-treatment-for-lupus/?fbclid=IwAR2f39AOHCFe7qTsiKSMlDM6Bb52HNGAZadJreKcju6Dm4W73X89Ankhp9o.