By Anthony O. Goriainoff

 

AstraZeneca PLC said Tuesday that Saphnelo has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus, or SLE, who show an insufficient response to standard treatment.

The London-listed biopharmaceutical company said the approval was based on the efficacy and safety data from Saphnelo's clinical development program, and that this is the first regulatory approval by the country's Ministry of Health, Labor and Welfare for a type 1 interferon receptor.

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

 

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

 

(END) Dow Jones Newswires

September 28, 2021 02:50 ET (06:50 GMT)

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