The approval by the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and was based on the positive results from the Phase III TULIP-SC trial. In the trial, subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe, active, autoantibody-positive SLE while receiving standard therapy.
SLE is a debilitating autoimmune condition impacting over 3.4 million people globally. It primarily affects women and can cause pain, rashes, fatigue, swelling in joints and fevers. In Europe, people with SLE have a two to three times increased risk of death compared to the overall population. While oral corticosteroids (OCS) are often used to provide relief from SLE symptoms, they are associated with adverse events and do not target the underlying drivers of the disease.
Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, Germany and investigator of the TULIP-SC trial, said, “EU approval of anifrolumab in a self-administered pre-filled pen is fantastic news for people living with systemic lupus erythematosus as clinicians now have the potential to reach a wider group of patients with this important medicine, which has been shown to significantly reduce disease activity and the risk of organ damage. Lupus has historically been overlooked, but with treatment recommendations now aiming for disease remission with earlier use of biologics and less reliance on oral corticosteroids, we’re beginning to see real momentum in delivering higher standards of care.”
Jeanette Andersen, Chair of Lupus Europe, said, “Lupus is a devastating disease that primarily impacts young women and is associated with painful symptoms and a substantial impact on daily life. Anifrolumab has been a much-needed innovation in systemic lupus erythematosus and at‑home administration now offers patients a more flexible and convenient option.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said, “We are committed to improving lupus care and since launch, Saphnelo IV infusion has transformed outcomes for tens of thousands of people living with systemic lupus erythematosus. With approximately 70% of SLE patients on biologics in Europe using a subcutaneous self-administration option, today’s approval means we can now offer the clinically meaningful benefits of Saphnelo while expanding patient choice in how and where they receive treatment.”
The safety profile of Saphnelo observed in the interim analysis of the TULIP-SC trial was consistent with the known clinical profile of the medicine administered as an intravenous (IV) infusion. The TULIP-SC interim results were presented during the American College of Rheumatology (ACR) Convergence 2025 annual meeting and will be published in a forthcoming medical journal.
Subcutaneous administration of Saphnelo is under regulatory review in several other countries around the world including the US and Japan. Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide including the US, EU and Japan, with regulatory reviews ongoing in other countries. To date, more than 40,000 patients globally have been treated with Saphnelo.
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