August 2, 2021

The U.S. FDA has approved Saphnelo™ (anifrolumab-fnia), manufactured by AstraZeneca, to treat moderate to severe systemic lupus erythematosus (SLE) in adults who are receiving standard therapy. Saphnelo is the first FDA-approved drug in a new class of medications known as type I interferon receptor antagonists.

SLE is an autoimmune disorder and the most common form of lupus. It occurs when the body’s immune system attacks and damages healthy tissues. The severity of the disease can range from mild to life- threatening, with signs and symptoms that include fatigue, fever, seizures, and issues with major organs such as the lungs, heart, and kidneys. Over half of individuals diagnosed with SLE develop permanent organ damage.

Saphnelo provides a new approach to treating SLE by blocking the action of type I interferons, a group of proteins that play a role in the body’s immune response. Most adults who have SLE also have an increase in type I interferon activity in the body, which has been associated with greater disease activity and severity. In clinical trials, a higher proportion of patients who received Saphnelo and standard-of-care therapy saw a reduction in overall disease activity than those on placebo plus standard of care. They were also more likely to have a sustained reduction in the use of oral corticosteroids, which are a current treatment option for SLE.

Under the recommended dosing, Saphnelo is administered as a 30-minute, 300mg intravenous infusion once every four weeks. Saphnelo has a wholesale acquisition cost (WAC) of $4,600.54 per 300mg vial.

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