By Anthony O. Goriainoff

 

AstraZeneca PLC said Monday that its lupus treatment Saphnelo has been recommended for marketing authorization in the European Union.

The London-listed biopharmaceutical company said Saphnelo is an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus, or SLE.

The company said the European Medicines Agency's Committee for Medicinal Products for Human Use based its opinion on results from Saphnelo's clinical development program, which included the TULIP Phase 3 trials and the MUSE Phase 2 trial. The company said the Phase 3 trial has started.

"Saphnelo was recently approved in the U.S., Japan and Canada for the treatment of SLE, and regulatory reviews are ongoing in additional countries," the company said.

 

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

 

(END) Dow Jones Newswires

December 20, 2021 02:37 ET (07:37 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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