Saphnelo approved to treat systemic lupus erythematosus

AstraZeneca’s Saphnelo (anifrolumab-fnia) was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. Saphnelo is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with SLE.

The approval was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trials. In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved a sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy. This marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist.

“Our treatment goals in SLE are to reduce disease activity, prevent organ damage from either the illness itself or the medications, especially steroids, and improve one’s quality of life,” stated Dr Richard Furie, principal investigator of the Saphnelo clincical development programme. “Today’s approval of anifrolumab represents a big step forward for the entire lupus community. Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use.”

“Today’s landmark approval of Saphnelo is the culmination of years of AstraZeneca’s pioneering research in the type I interferon pathway, a central driver in SLE pathophysiology. This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease,” added Executive Vice President of BioPharmaceuticals Research and Development, Dr Mene Pangalos.

The adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough.

Results from the TULIP-2 Phase III trial were published in The New England Journal of Medicine (NEJM) in January 2020, results from the TULIP-1 Phase III trial were published in The Lancet Rheumatology in December 2019 and results from the MUSE Phase II trial were published in Arthritis & Rheumatology in November 2016.

Saphnelo is under regulatory review for SLE in the EU and Japan. The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.