Saphnelo is a first-in-class type I interferon receptor antibody for patients with moderate to serve systemic lupus erythematosus.
Saphnelo (anifrolumab), licensed by AstraZeneca, 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, despite receiving standard therapy.
Systemic lupus erythematosus is a long-term condition that causes joint pain, skin rashes and tiredness. There is currently no cure, but symptoms can improve if treatment is started early.
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. The approval follows the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2021.
The first biologic for systemic lupus erythematosus
Saphnelo is the first biologic for systemic lupus erythematosus approved in Europe with an indication that is not restricted to patients with a high degree of disease activity. This condition affects approximately 250,000 people in Europe, and most are women aged between 15 and 45.
During the 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. It resulted in a minimisation of OCS use whilst reducing the risk of organ damage.
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 erythematosus 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 systemic lupus erythematosus, and regulatory reviews are ongoing in additional countries. The Phase III trial in systemic lupus erythematosus using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.