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AstraZeneca says lupus treatment gets US FDA approval

ALN

AstraZeneca PLC on Monday said its self-administered lupus treatment has been approved in the US.

The US Food & Drug Administration has approved the Saphnelo Pen once-weekly autoinjector on top of the standard therapy.

‘The approval by the US Food & Drug Administration was based on results from the phase III TULIP-SC trial, which showed that subcutaneous administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe systemic lupus erythematosus while receiving standard therapy,’ AstraZeneca said.

Lupus is an autoimmune disease that can cause skin rashes and pain in the joints.

Shares in AstraZeneca were 0.6% higher at 14,046.00 pence each in London on Monday morning.

The company releases first quarter results on Wednesday.

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