AstraZeneca's Saphnelo approved in Japan for lupus

28 September 2021

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 of the AstraZeneca (LSE: AZN) drug by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical development program, including the TULIP Phase III trials and the MUSE Phase II study.

"Saphnelo is the first and only type I IFN receptor antagonist to receive approval in Japan"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.

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