AstraZeneca lupus treatment wins EU marketing approval
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AstraZeneca's lupus treatment has received marketing authorisation by the European Union, the company said on Monday.
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Its Saphnelo drug is an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy.
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.
"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.