Important Message from CEO Kenneth Farber:  U.S. FDA Approves New Lupus Treatment
Important Message from CEO Kenneth Farber: U.S. FDA Approves New Lupus Treatment

August 2, 2021

Dear Friend of the Lupus Research Alliance,

As we reported this morning, the lupus community has much to celebrate with the U.S. Food and Drug Administration (FDA) approval of anifrolumab-fnia (brand name, Saphnelo™). As a first-in-class and only new treatment for systemic lupus erythematosus in a decade, this approval marks a major milestone. Congratulations to AstraZeneca, the company that spent years developing this medicine and testing it in clinical trials.

We are very excited about this announcement for many reasons. Most importantly, after a decade-long drought, we finally have a new medication for adults with moderate to severe SLE. While two new treatments were recently approved to treat lupus nephritis, it’s been too long since we’ve had a new treatment for generalized SLE. The last approval was for belimumab (brand name Benlysta) in 2011.

Another reason we’re delighted about this approval is because it demonstrates yet again the LRA’s efforts to fund biomedical research is paying off; there really is a pot of gold at the other end of the rainbow. Since 2000, our organization began to explore whether a substance produced by the immune system called interferon might be implicated in inciting some of the symptoms of lupus. LRA invested millions of dollars in 40 research grants to top lupus experts who ultimately determined that one of the most prominent features of lupus was the overly robust action of interferon.

There are many forms of interferon, but they all share a common purpose — to promote inflammation which is one of the first lines of defense against viral infections. Interferons (a class of immune-system substances called cytokines) have a very important role in marshalling the immune system to fight infection, but you know what they say about too much of a good thing. When it comes to interferon, 60-80 percent of lupus patients have too much of a good thing. Once the important role of interferon in lupus was proven, pharmaceutical companies had a target to shoot for — to develop a medicine that tamped down the excessive activity of this substance. That’s exactly what Saphnelo does.

Many people deserve congratulations for this excellent news. The interferon experts who spent decades understanding the role of interferon in lupus (a process that continues to this day). AstraZeneca, the company that persevered and finally emerged with an effective therapy for lupus, did a truly phenomenal job. All of us who care about lupus are fortunate to have the scientists and staff at AstraZeneca and many other companies as allies working to find better therapies for the disease. Most importantly, the lupus patients who participated in the clinical trials testing Saphnelo are the real heroes of the story because without them, we would not be celebrating this success today.

All of us at the Lupus Research Alliance are committed to unraveling the causes of lupus so many other new, targeted therapies can be developed. With this approval, we are more confident than ever that our goal to find more targeted therapies will be achieved. Ultimately, we want to find ways to prevent — and cure lupus.

There’s only one way to find out whether this medicine will be right for you — a discussion with your rheumatologist. Meanwhile, please share in the excitement this approval means for the entire lupus community – it’s an historic milestone that affirms research discoveries and opens doors to future advances.

With warm regards,

Kenneth Farber

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