Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union 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. There are approximately 250,000 people with SLE in Europe, and most are women who are diagnosed between the ages of 15 and 45.

The approval by the European Commission was based on results from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial. 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. Minimising OCS use while reducing disease activity is an important treatment goal in SLE to reduce the risk of organ damage. The approval follows the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2021.

Ronald van Vollenhoven, Chair of Rheumatology and Director of the Amsterdam Rheumatology Center in Amsterdam, the Netherlands 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, 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.”

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.

Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE, and regulatory reviews are ongoing in additional countries. 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.