AstraZeneca's Saphnelo Approved in Japan for SLE
28 September 2021 - 5:05PM
Dow Jones News
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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