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Saphnelo approved in Japan for systemic lupus erythematosus.

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Last updated:8th Oct 2021
Published:28th Sep 2021
AstraZeneca’s Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease, who show insufficient response to currently available treatment.

The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) 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.

This decision marks the first regulatory approval by the MHLW for a type I interferon (type I IFN) receptor antagonist in Japan. Type I IFN plays a central role in the pathophysiology in lupus and increased type I IFN signalling has been shown to be associated with increased disease activity and severity.

Condition: Systemic Lupus Erythematosus (SLE)
Type: drug

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