AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy.
Saphnelo is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity. SLE is a serious and complex autoimmune condition that can affect any organ, and patients often experience inadequate disease control, long-term organ damage and poor health-related quality of life.1-3 There are approximately 250,000 people with SLE in Europe, and most are women who are diagnosed between the ages of 15 and 45.4
The approval was based on results from a clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial.5-7 Across clinical trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo.5-7 Minimising OCS use while reducing disease activity is an important treatment goal in SLE to reduce the risk of organ damage.8,9 The approval follows the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2021.
The most frequent adverse reactions that occurred in patients who received Saphnelo in the controlled clinical trials included upper respiratory tract infection, bronchitis, infusion-related reactions and herpes zoster.5-7
Ronald van Vollenhoven, Chair of Rheumatology and Director of the Amsterdam Rheumatology Center in Amsterdam said, “In Europe, there have been limited treatment options for patients living with systemic lupus erythematosus and many patients face poor outcomes. Anifrolumab targets the type I interferon pathway, which is known to play a central role in lupus pathophysiology. Today’s approval is an important step forward in treating this disease.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said: “Saphnelo is the first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade and is the only biologic not restricted to patients with a high degree of disease activity. Saphnelo has demonstrated clinically meaningful benefits and we look forward to bringing it to patients as quickly as possible.”
- Centers for Disease Control and Prevention. Systemic Lupus Erythematosus (SLE). Available at: https://www.cdc.gov/lupus/facts/detailed.html [Last accessed: February 2022]
- American College of Rheumatology. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis & Rheumatology. 1999; 42: 1785-1796.
- Touma Z, et al. Current and future therapies for SLE: obstacles and recommendations for the development of novel treatments. Lupus Sci Med. 2017; 4: e000239.
- Cornet A, et al. Living with systemic lupus erythematosus in 2020: a European patient survey. Lupus Sci Med. 2021; 8: e000469.
- Morand EF, et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221.
- Furie R, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019; 1 (4): e208-e219.
- Furie R, et al. Anifrolumab, an Anti–Interferon‐α Receptor Monoclonal Antibody, in Moderate‐to‐ Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017; 69 (2) :376-386.