Company: AZN
Filing Date: 2025-12-16
Form Type: 6-K
Source: 0001654954-25-013974
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-12-16
Form: 6-K
Chunk 2
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 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. 13-15 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. 16

#### Notes

#### Financial considerations
AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. Under the agreement AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.

#### Systemic lupus erythematosus
SLE is a chronic and complex autoimmune disease in which the immune system attacks healthy tissue in the body. 4 An estimated 50% of people with SLE have irreversible organ damage within five years of diagnosis due to long-term corticosteroid use and disease activity. 11,17 Even a small reduction in daily oral corticosteroid use (for example 1 mg/day) can lower the risk of organ damage. 18 Recent updates to clinical guidelines elevate the importance of treating to target remission or low disease activity and minimising the use of oral corticosteroids. 6,7

#### TULIP-SC
TULIP-SC was a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous administration of anifrolumab versus placebo in participants aged 18 to 70 years with moderate to severe, active, autoantibody-positive SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants). 19

The reduction