Drugmaker AstraZeneca said on Monday that Saphnelo had been approved in the US for the treatment of adult patients already receiving standard therapy for moderate to severe systemic lupus erythematosus.
AstraZeneca stated the approval by the Food and Drug Administration was based on efficacy and safety data from its Saphnelo clinical development programme, which included two Phase III trials and a Phase II trial.
In the trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved a sustained reduction in oral corticosteroid use when compared to placebo.
The FTSE 100-listed firm added that the FDA’s decision also marked the first regulatory approval for a type I interferon receptor antagonist and the only new treatment approved for SLE in more than 10 years.
AZN’s Mene Pangalos said: “Today’s landmark approval of Saphnelo is the culmination of years of AstraZeneca’s pioneering research in the type I interferon pathway, a central driver in systemic lupus erythematosus pathophysiology.
“This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease.”
As of 0910 BST, AstraZeneca shares were down 0.62% 8,217.0p.