The US Food and Drug Administration (FDA) has approved AstraZeneca’s Saphnelo (anifrolumab) for the treatment of moderate to severe systemic lupus erythematosus (SLE).
The FDA has specifically cleared Saphnelo for the treatment of adult SLE patients with moderate to severe disease who are also receiving standard therapy.
Saphnelo becomes the first type I interferon (type I IFN) receptor agonist to receive regulatory approval, and is also the only new treatment to be cleared for SLE in over ten years, AZ added in a statement.
The FDA approval is based on efficacy and safety data from AZ’s Saphnelo clinical development programme, which included the two TULIP Phase III trials and the MUSE Phase II trial.
According to these studies, more patients receiving Saphnelo treatment experienced a reduction in overall disease activity across organ systems, including skin and joints, and also achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo.
Adverse reactions that occurred more frequently in Saphnelo-treated patients in these trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough.
“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.
SLE is the most common form of lupus, affecting up to 300,000 people in the US alone and disproportionately affects the African-American, Hispanic and Asian populations. It is a complex autoimmune condition that can affect any organ, with SLE patients often experiencing long-term organ damage as well as poor health-related quality of life.