AstraZeneca secures US approval for lupus drug Saphnelo

The US Food and Drug Administration (FDA) has granted marketing approval for AstraZeneca's Saphnelo (anifrolumab). The drug is intended for adult patients suffering from moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

The approval is based on efficacy and safety data from the Saphnelo clinical development program, including two Phase III TULIP trials and one Phase II MUSE trial. The trials showed that patients treated with Saphnelo experienced a greater reduction in overall disease activity across organ systems, including skin and joints. Furthermore, a sustained reduction in the use of oral corticosteroids was observed compared to the placebo group.

Saphnelo is the first type I interferon (IFN) receptor antagonist to receive approval and represents the first new medicine for SLE in over a decade. Type I IFN plays a central role in the pathophysiology of lupus, and increased signaling is associated with increased disease activity and severity.

Systemic lupus erythematosus is an autoimmune disease that can affect any organ and lead to debilitating symptoms, long-term organ damage, and reduced quality of life. The condition affects an estimated 300,000 people in the US and disproportionately affects African-American, Hispanic, and Asian populations.