Saphnelo is the first therapy in over a decade for patients with moderate to severe systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the EU for the treatment of moderate to severe systemic lupus erythematosus (SLE), a serious and complex autoimmune condition that can affect any organ.
Approximately 250,000 suffer with SLE in Europe and there are limited treatment options for patients with the condition. Saphnelo is the first new medicine for SLE to gain approval in Europe in over a decade, and the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity.
Most patients with SLE are women, who are diagnosed between the ages of 15 and 45. Patients often experience inadequate disease management, long-term organ damage and poor health-related quality of life.
Saphnelo has been approved in the 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. The European Commission’s approval is based on results from the Saphnelo clinical development programme, including the TULIP phase 3 trials and the MUSE phase 2 trial.
Ronald van Vollenhoven, Chair of Rheumatology and director of the Amsterdam Rheumatology Center in Amsterdam, the Netherlands commented: “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.”
Across clinical trials, more patients treated with Saphnelo experienced a reduction in overall disease activity, and achieved sustained reduction in oral corticosteroid (OCS) use, compared to placebo. OCS are steroids, used as anti-inflammatory medicine for a wide range of conditions, including lupus. Minimising OCS use while reducing disease activity is an important treatment goal in SLE, to reduce the risk of organ damage.
Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE. Regulatory reviews are ongoing in additional countries.
