AstraZeneca's Saphnelo Approved in U.S. for Moderate-to-Severe SLE
02 August 2021 - 8:35AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Monday that the U.S. Food and Drug
Administration approved its lupus treatment, Saphnelo, for adult
patients with moderate-to-severe systemic lupus erythematosus, or
SLE, who are receiving standard therapy.
The U.K.-Swedish drugmaker said that the approval was based on
the efficacy and safety data from Saphnelo's clinical development
program, and that this was the only new treatment approved for SLE
in more than 10 years.
The company said Saphnelo was under regulatory review for SLE in
the European Union, as well as in Japan.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 02, 2021 02:35 ET (06:35 GMT)
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