Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Tuesday that Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE) who show insufficient response to currently available treatment.

SLE, also known as lupus, is an autoimmune disease in which the immune system attacks healthy tissue in the body. Symptoms can include 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.

The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety data from trials which showed that 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.

This decision marks the first regulatory approval by the MHLW for a type I interferon (type I IFN) receptor antagonist in Japan.