FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.1

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy.1,2,3,4

This marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist and the only new treatment approved for SLE in more than 10 years.5,6 Type I IFN plays a central role in the pathophysiology of lupus and increased type I IFN signalling is associated with increased disease activity and severity.7,8,9,10,11

Dr. Richard Furie, Chief of the Division of Rheumatology at Northwell Health, New York, US and a principal investigator in the Saphnelo clinical development programme, said: “Our treatment goals in systemic lupus erythematosus 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. 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.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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 systemic lupus erythematosus pathophysiology. This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease.”

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.1

SLE, the most common form of lupus affecting up to 300,000 people in the US, disproportionately affects the African-American, Hispanic and Asian populations.12 It is a complex autoimmune condition that can affect any organ, and people often experience debilitating symptoms, long-term organ damage and poor health-related quality of life.12,13,14,15

Results from the TULIP-2 Phase III trial were published in The New England Journal of Medicine 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.