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FDA Approves AstraZeneca's Saphnelo To Treat Systemic Lupus Erythematosus

The U.S. Food and Drug Administration approved AstraZeneca plc.'s (AZN.L,AZN) Saphnelo or anifrolumab-fnia for the treatment of adult patients with moderate to severe systemic lupus erythematosus or SLE who are receiving standard therapy.

Systemic lupus erythematosus is an autoimmune disease in which the immune system attacks healthy tissue in the body. 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. More than 50% of patients with SLE develop permanent organ damage, caused by the disease or existing treatments, which exacerbates symptoms and increases the risk of mortality.

Saphnelo is under regulatory review for systemic lupus erythematosus in the EU and Japan. The Phase III trial in systemic lupus erythematosus using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

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

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