FDA approves first Lupus treatment in a decade

Earlier this year, the FDA approved the first new treatment for Lupus since 2011. This is a major win for the millions of patients who are impacted by this condition, and the advocacy groups, plans, and providers who serve them. Here’s what you need to know:

What is Lupus?
Lupus is an autoimmune disease (a condition in which your immune system attacks healthy tissue) that can cause inflammation and pain in any part of your body.

Lupus most commonly affects the skin, joints, and internal organs. This condition can be difficult to diagnose because it often mimics other diseases, and no two cases are exactly alike.

What is Saphnelo?
Saphnelo (anifrolumab-fnia) is a first-in-class treatment from AstraZeneca for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Saphnelo inhibits a key protein in the immune system, the IFNAR receptor, that amplifies signals from type I interferons–a process that can trigger major inflammation. This therapy targets the excessive type I interferon signature found in up to 80% of adults and 90% of children with Lupus.

Why does this matter?
Saphnelo is the first therapy for SLE to receive FDA approval since 2011–and only the second treatment to be approved in the last 50 years.

SLE is the most common form of Lupus, affecting up to 300,000 people in the US–a  disproportionate number of whom are Black, Latino, or Asian.

What does the industry say?
It is estimated that 1.5 million Americans, and more than 5 million people worldwide, have Lupus. However, clinical trials for new treatments have yielded few results over the past decades.

Healthcare providers and advocacy groups, like the Lupus Foundation of America, are celebrating this approval, and the new options it offers for patients.

For the past 18 months AstraZeneca has been working closely with patients and advocacy groups to build a patient support program for those who are prescribed Saphnelo. Throughout the process, they have put a particular emphasis on cultural competencies to ensure they are effectively communicating with the patient community.

Abarca will continue to communicate with our clients about Saphnelo and what it means for their pharmacy benefit.

In the meantime, we are encouraged by this approval and the steps that are being taken across the industry to ensure that patients get the information and support they need.

This blog was written by Elvis Rosario, Pharmacist, Clinical Serivces in Clinical Products & Services at Abarca.


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