FDA Approves Saphnelo™ as New Treatment for Lupus
The U.S. Food and Drug Administration (FDA) has approved Saphnelo™ (anifrolumab-fnia) as a treatment for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. Saphnelo is the third therapy for lupus to receive regulatory approval since 2011.
Developed by AstraZeneca, Saphnelo is the first therapy to dampen 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. This signature is associated with the risk for more severe lupus features.
In clinical trials, more patients who received Saphnelo in addition to standard therapy showed improvement than those who received a placebo along with standard therapy. Saphnelo showed benefits on overall lupus disease activity, skin lupus, joints, and the ability to taper down steroid doses.
“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.”
Link to Australia
With the announcement for the use of this drug in the USA, it now requires approval by Australia’s regulatory body the Therapeutic Goods Administration (TGA). If approved availability would then be dependent on whether the Federal Health Minister approves the drug to be placed on the Pharmaceutical Benefits Scheme (PBS). Lupus Association of NSW urges both the TGA and PBS to consider the continuing unment demand of SLE patients in Australia. This would then follow on from the decision not to recommend Benlysta® (belimumab) to be included on the PBS.
As a result of Monash Universities world-class standing in the field, Professor Eric Morand was lucky enough to be the global chief investigator of the TULIP-2 trial of anifrolumab, the first positive phase 3 trial for a lupus drug in 10 years, and pivotal in the FDA approval granted in August. Professor Morand said, “The FDA approval of anifrolumab potentially allows thousands of lupus patients to benefit. Decreased disease activity, along with reduced steroid use, form the pillars of treatment goals in lupus and anifrolumab has shown these effects.” (Reference: Lupus Research Alliance). He added, “I am keen for this drug to be available to Australian lupus patients, as I think it has the potential to be truly a game changer”.
Professor Eric Morand is Head of the School of Clinical Sciences at Monash Health, Monash University’s largest clinical school, and a physician-scientist.
He specialises in the study of systemic lupus erythematosus. He is founder of the Monash Lupus Clinic, Australia’s largest research-grounded clinic for patients with SLE, a founding member of the Australian Lupus Registry & Biobank, and Chair of the Asia-Pacific Lupus Collaboration. His clinical research focuses on improving endpoints for clinical research in lupus. His lab has studied the biology of glucocorticoids in rheumatic disease and lupus since 1996.