AstraZeneca's Saphnelo Approved in EU for Treatment of Systemic Lupus Erythematosus
16 Februar 2022 - 8:52AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Wednesday that its lupus treatment Saphnelo
as been approved in the European Union for the treatment of
moderate-to-severe systemic lupus erythematosus, the most common
type of lupus.
The London-listed biopharmaceutical company said the approval by
the European Commission was based on results from the Saphnelo
clinical development program.
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 company said more patients treated with Saphnelo in clinical
trials experienced a reduction in overall disease activity across
organ systems and achieved sustained reduction in oral
corticosteroid use when compared with a placebo.
Saphnelo has recently been approved in the U.S., Japan and
Canada for the treatment of SLE and there are regulatory reviews
continuing in additional countries, the company said.
"Saphnelo is the first new medicine for systemic lupus
erythematosus to gain approval in Europe in over a decade and is
the only biologic not restricted to patients with a high degree of
disease activity," AstraZeneca said.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
February 16, 2022 02:37 ET (07:37 GMT)
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