Source: Sharecast
AstraZeneca said the FDA approval, for adults also receiving standard therapy, follows its recent Phase III TULIP‑SC trial, which showed that subcutaneous dosing delivered a "statistically significant and clinically meaningful" reduction in disease activity versus placebo in patients with moderate to severe SLE on background treatment.
The FTSE 100-listed firm stated the safety profile was consistent with that seen with intravenous administration of Saphnelo.
Ruud Dobber, execvutive vice president of AstraZeneca's biopharmaceuticals business unit, said: "Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. The approval of the Saphnelo Pen represents a significant step forward in expanding Saphnelo's clinical benefits to more people living with systemic lupus erythematosus."
As of 0830 BST, AstraZeneca shares were up 0.62% at 14,042p.
Reporting by Iain Gilbert at Sharecast.com
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