New medication approved in the US to treat Lupus patients!
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, expanding treatment options for this medically underserved and life-threatening autoimmune disease. It is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with SLE!
The Food and Drug Administration (FDA) approval was based on efficacy and safety data from the Saphnelo clinical development program. In the trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo.
George Tsokos 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 significant 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.
“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 of the Lupus Foundation of America.
Shannon Lee, a Lupus Foundation of America ambassador diagnosed with lupus 11 years ago, welcomed the news of a new treatment for lupus that can cut down on the use of oral corticosteroids, which can damage the body over time. “Steroids can cause many serious and life-threatening side effects, some of which I experienced while taking them before having to stop due to the issues they caused me,” said Lee. “Having another potential treatment option like Saphnelo is extremely exciting.”
Richard Furie, Chief of the Division of Rheumatology at Northwell Health, New York, US and a principal investigator in the Saphnelo clinical development program, said: “Our treatment goals in systemic lupus erythematosus are to reduce disease activity, prevent organ damage from either the illness itself or the medications, especially steroids, and improve one’s quality of life. Today’s approval of anifrolumab represents a big step forward for the entire lupus community. Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use.”
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