Life With Lupus: FDA approves new SLE treatment
This article is not intended to be medical or pharmaceutical advice.
The article is simply a report on a newly announced Systemic Lupus Erythematosus (SLE) medication.
As always, you should consult medical professionals with regard to your own health and decisions.
Personally, I intend to do the same at my next Rheumatologist appointment and ask if this new treatment is right for me.
Many press releases and announcements today in the media about the Food & Drug Administration (FDA) approval of a new SLE treatment named Saphnelo (anifrolumab).
Manufactured by AstraZeneca, Saphenlo is described as the following on the pharmaceutical company's website...
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.(1)
The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. In these 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, with both groups receiving standard therapy.(1,2,3,4)
See "References" for footnotes 1-4
Acronyms used above...
- MUSE: Maximum Usage Systemic Exposure
- TULIP: Treatment of Uncontrolled Lupus via the Interferon Pathway
Based on the box and vial pictured in a FiercePharma article, Saphnelo is a intravenous infusion drug. The sample pictured indicates a 300mg single dose vial. No indication of other dosages or frequency.
Per the same FiercePharma article...
It marks the first U.S. go-ahead for SLE in about 10 years, after GlaxoSmithKline’s Benlysta broke nearly five decades of stagnancy in the field with an FDA approval in 2011.
Unlike Benlysta, which inhibits B-cell stimulating factor, Saphnelo is a type I interferon receptor antagonist, and it’s the first drug in its class to cross the regulatory finish line.
AstraZeneca has touted Saphnelo’s blockbuster potential, given SLE affects up to 300,000 people in the U.S.
Today's announcement was also met with praise and support from the Lupus Foundation of America...
“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, 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."
For more information about Saphnelo, please see the following sites...
- AstraZeneca website and press release excerpt footnotes...
- 1. Saphnelo [anifrolumab-fnia] US prescribing information; 2021.
- 2. Morand E, et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221. Accessed July 2021.
- 3. Furie R, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. Accessed July 2021.
- 4. Furie R, et al. Anifrolumab, an Anti–Interferon‐α Receptor Monoclonal Antibody, in Moderate‐to‐Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017;69(2):376-386. Accessed July 2021.
- Lupus Foundation of America
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