AstraZeneca lupus drug gets approval in Japan
AstraZeneca said on Tuesday that its Saphnelo (anifrolumab) drug has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE).
The approval by the Japanese Ministry of Health, Labour and Welfare was based on efficacy and safety data from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial.
In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said: "Saphnelo is the first and only type I interferon receptor antagonist to receive approval in Japan and represents a major advance in treating systemic lupus erythematosus, a complex heterogenous disease that is challenging to treat and often debilitating for patients.
"We will now work to bring this medicine to patients in Japan living with this disease as quickly as possible."
SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body. AstraZeneca said that 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.