FDA Approves Anifrolumab-Fnia for Treatment of Systemic Lupus Erythematosus

The US Food and Drug Administration (FDA) announced the approval of anifrolumab-fnia (Saphnelo™) for the treatment of moderate to severe systemic lupus erythematosus (SLE). The decision to approve anifrolumab-fnia, a first-in-class human monoclonal antibody targeting type I interferons, marks the first approval in over a decade for SLE treatment.

The Drug

Anifrolumab-fnia blocks type I interferons, a main factor that leads to tissue damage and symptom severity in patients with SLE. Approximately 60 to 80 percent of adults have high levels of this interferon.

The Trials

The Phase 3 clinical trials, TULIP-1 and TULIP-2, have proven the safety and efficacy of anifrolumab-fnia for treating SLE. Results indicated the drug reduced flares and allowed for lowered steroid use. Additionally, patients receiving anifrolumab-fnia had reductions in arthritis symptoms and severity of skin rash.

Background

Recent studies, such as those funded by the Lupus Research Alliance (LRA), have played a pivotal role in analyzing the molecules’ role in treating patients with SLE.

“The role of interferon in lupus has been supported by the science for years but has long awaited this formal proof of benefit in a clinical trial,” stated Eric Morand, MD, PhD, an LRA Distinguished Innovator Award recipient. “The FDA approval of anifrolumab-fnia 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-fnia has shown these effects. As an LRA investigator, I am extremely proud to have been involved in this landmark in the journey to improve the lives of people with lupus.”