FDA approves AstraZeneca’s anifrolumab for treating lupus
pharmafile | August 3, 2021 | News story | Manufacturing and Production |
The FDA has approved Saphnelo (anifrolumab) for the treatment of moderate-to-severe systemic lupus erythematosus (SLE), the most common form of lupus.
This makes anifrolumab the first-of-its-kind, as it’s the first regulatory approval for a type I interferon (type I IFN) receptor antagonist.
This is the first new lupus treatment to have been approved in over a decade.
The approval by the FDA was based on data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial.
In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo.
Dr. Richard Furie, Chief of the Division of Rheumatology at Northwell Health, and a Principal Investigator in the Saphnelo clinical development programme, said: “Our treatment goals in systemic lupus erythematosus are to reduce disease activity, prevent organ damage from either the illness itself or the medications, especially steroids, and improve one’s quality of life.
“Today’s approval of anifrolumab represents a big step forward for the entire lupus community. Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.”
SLE affects up to 300,000 people in the US, and disproportionately affects the African-American, Hispanic and Asian populations.
It is an autoimmune condition that can affect any organ, and people often experience debilitating symptoms, long-term organ damage, and poor health-related quality of life.
