Company: AZN
Filing Date: 2025-10-20
Form Type: 6-K
Source: 0001654954-25-011943
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-10-20
Form: 6-K
Chunk 1
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 results from the Phase III TULIP-SC trial, which showed that 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 The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion. 3-5

Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, Germany and investigator of the TULIP-SC trial said: "The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment. With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimising steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients."

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: " Saphnelo IV infusion has already helped transform outcomes for many patients with systemic lupus erythematosus. With this positive CHMP recommendation, we're one step closer to offering the clinically meaningful benefits of Saphnelo to more people in a convenient, once-weekly self-administration option. We are also advancing a robust development programme to explore Saphnelo's potential in other diseases where type 1 interferon plays a central role, including cutaneous lupus erythematosus, lupus nephritis, myositis and systemic sclerosis."

SLE is a debilitating autoimmune condition impacting more than 3.4 million people globally. 6 It primarily affects women and can cause pain, rashes, fatigue, swelling in joints and fevers. 7-11 In Europe, people with SLE have a two to three times increased risk of death compared to the overall population. 12 While oral corticosteroids 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. 13-15 Approximately 70% of people in Europe who are on biologic therapy for