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Subject: FDA

Lupus Foundation of America Celebrates FDA Approval of Saphnelotm (Anifrolumab-fnia) as a New Treatment for Lupus

WASHINGTON, Aug. 2, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Saphnelotm (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.

"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. "The pipeline of potential new treatments for lupus remains vibrant, and the Lupus Foundation of America continues its work to bring down barriers to lupus drug development and ensure that people with lupus will have access to the medications they need to improve their quality of life."

Dr. George Tsokos, a member of the Lupus Foundation of America Medical-Scientific Advisory Council, 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.

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."

"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, Allegheny Health Network Medicine Institute and Director, Lupus Center of Excellence.  "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."

The Lupus Foundation of America's research during the 1980s contributed to the development of Saphnelo through its support of research on interferons. In recent years, the Foundation helped by educating people with lupus about the importance of participating in clinical trials for this new therapy. As part of its efforts to continue engaging people with lupus in ongoing research, the Foundation created an online data platform, RAYtm (Research Accelerated by You). This platform enables people with lupus and caregivers to share their lupus experiences to help researchers accelerate new treatments and improve disease outcomes.

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. More information is available from the company news release.

About Lupus

Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body.  It is difficult to diagnose, hard to live with, and a challenge to treat. Lupus is a cruel mystery because it is hidden from view and difficult to describe, has a range of symptoms, strikes without warning, and has no known cause and no known cure. Its health effects can range from a skin rash to a heart attack. Lupus is debilitating and destructive and can be fatal, yet research on lupus remains underfunded relative to diseases of similar scope and devastation.

About the Lupus Foundation of America

The Lupus Foundation of America is the national force devoted to solving the mystery of lupus, one of the world's cruelest, most unpredictable and devastating diseases, while caring for those who suffer from its brutal impact. Through comprehensive research, education, and advocacy programs, we lead the fight to improve the quality of life for all people affected by lupus. Learn more about the Lupus Foundation of America at lupus.org.

Mike Donnelly
(202) 349-1162

SOURCE Lupus Foundation of America

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