Company: AZN
Filing Date: 2025-09-17
Form Type: 6-K
Source: 0001654954-25-010847
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-09-17
Form: 6-K
Chunk 2
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 using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. 5 The BICLA requires improvement in all organs with disease activity at baseline with no new flares. 5

The TULIP-SC interim results are under regulatory review and will be presented during the American College of Rheumatology (ACR) Convergence 2025 annual meeting, 24-29 October 2025.

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 38,000 patients globally have been treated with Saphnelo . 17

#### 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 an autoimmune disease in which the immune system attacks healthy tissue in the body. 18 It is a chronic and complex disease with a variety of clinical manifestations that can impact many organs and can cause a range of symptoms, including pain, rashes, fatigue, swelling in joints and fevers. 9

Over 3.4 million people globally are affected by SLE, and it is among the leading causes of death in young women in the US. 7,19 Living with SLE can be painful, debilitating, have a profound impact on patients' mental and financial well-being, and disproportionately affects women in their prime, and those of Asian, Black or Hispanic racial/ ethnic backgrounds. 6,7,11,20,21

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. 13,21,22 Even a small reduction in daily steroid use (for example 1 mg/day) can lower the risk of organ damage. 23

#### TULIP-SC
TULIP-SC is a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and