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AstraZeneca’s Saphnelo approved in Japan for SLE

Mene Pangalos

Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease.

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.

“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.”

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.

“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,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZenec.

Approved in the US

Saphnelo is approved in the US for the treatment of moderate to severe SLE and is under regulatory review for SLE in the EU. A Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

Financial considerations

AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. Under the agreement AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.

Photo of Mene Pangalos: AstraZeneca