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Subcutaneous Saphnelo approved in EU
AstraZeneca's Saphnelo has received European Union approval for subcutaneous self-administration via a pre-filled pen for adult patients with systemic lupus erythematosus, offering a more convenient option with the same clinical benefits as the intravenous infusion. This approval, based on positive Phase III TULIP-SC trial results demonstrating a significant reduction in disease activity, expands patient choice and accessibility, with regulatory reviews for subcutaneous administration ongoing in the US and Japan. AstraZeneca will pay Bristol-Myers Squibb a low to mid-teens royalty on sales dependent on geography. Disclaimer*
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[{"type":"text","content":"\n\n16 December 2025\n \nSaphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus\n \nConvenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion\n \nAstraZeneca's Saphnelo (anifrolumab) has been approved in the European Union (EU) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.\n \nThe 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.1 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.1,2\n \nSLE is a debilitating autoimmune condition impacting over 3.4 million people globally.3 It primarily affects women and can cause pain, rashes, fatigue, swelling in joints and fevers.4-8 In Europe, people with SLE have a two to three times increased risk of death compared to the overall population.9 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.10-12\n \nProfessor 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.\"\n \nJeanette Andersen, Chair of Lupus Europe, said: \"Lupus is a devastat...