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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new subcutaneous route of administration for Saphnelo (anifrolumab), used as an add-on treatment in adults with systemic lupus erythematosus (SLE).
SLE is a chronic autoimmune disease in which the immune system attacks normal cells and tissues, causing inflammation and organ damage. It can affect almost any organ in the body and can cause pain, fatigue, and joint swelling.
The disease is believed to affect between 150,000 and 270,000 people in the European Union. There is high unmet need for new therapies for SLE, for which there is no cure.
Saphnelo received market authorization throughout the EU in 2022 and is under additional monitoring, meaning it is monitored more intensively than other medicines.
The EMA previously considered that Saphnelo provides a modest but clinically meaningful reduction in disease activity in patients with SLE. Two main studies with 822 patients over the course of 1 year found that 300 mg of Saphnelo was more effective as an add-on to standard treatment than a placebo in reducing disease activity.
In the first study, disease activity decreased in 47% of patients treated with Saphnelo compared with 30% of patients who were given placebo. In the second study, disease activity decreased in 48% of patients treated with Saphnelo compared with 32% of those who received placebo.
The active substance, anifrolumab, is a monoclonal antibody that blocks the type I interferon (IFN) receptor, preventing interferon from overstimulating the immune system and attacking healthy tissues.
Saphnelo can be obtained only with a prescription. Prior to the adoption of this new subcutaneous route, it has been given as an infusion into a vein. The recommended dose is 300 mg given over 30 minutes every 4 weeks.
