AstraZeneca Says Saphnelo Approved To Treat SLE In Japan

AstraZeneca (AZN), a global biopharmaceutical company, on Tuesday, said its Saphnelo (anifrolumab), a first-in-class type I interferon receptor antibody, has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE).

SLE is a serious autoimmune disease, which shows an 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 program. This also includes the TULIP Phase III trials and the MUSE Phase II trial, the Cambridge-headquartered firm said in a statement.

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.

The adverse reactions that occurred more frequently in patients who received Saphnelo in clinical trials comprised upper respiratory tract infection, bronchitis, infusion-related reactions, hypersensitivity reactions, and herpes zoster, the company added.

SLE can affect any organ, and people often experience inadequate disease control, long-term organ damage, and poor health-related quality of life.

SLE is designated as an intractable disease in Japan through a program that incentivizes research and development of drugs to treat rare diseases that lack effective treatments, and also helps reduce the cost burden on patients.

There are approximately 60,000 registered patients with SLE in Japan, and the majority are women diagnosed before age 45.

Saphnelo has been approved in the U.S. for the treatment of moderate to severe SLE and is under regulatory review for SLE in the EU.

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