AstraZeneca's Saphnelo Approved in U.S. for Moderate-to-Severe SLE

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 [e-mail]

(END) Dow Jones Newswires

08-02-21 0235ET