AstraZeneca’s FDA Approval Brings New Hope to the Lupus Community

Astra_Bodo Marks/picture alliance via Getty

Bodo Marks/picture alliance via Getty Images

Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.

Saphnelo is a type I interferon receptor antagonist acquired through an agreement with Medarex in 2004. Today’s approval for marks the first drug in over a decade to treat systemic lupus erythematosus or SLE. Since Bristol Myers Squibb bought out Medarex in 2009, AstraZeneca will pay some low- to mid-teens royalties to BMS.

Systemic lupus erythematosus is the most common form of lupus and affects up to 300,000 people in the U.S. alone. An autoimmune condition, patients can often experience long-term organ damage and poor quality of life due to their health. Given intravenously, Saphnelo blocks type 1 interferons, which are a main factor in leading to tissue damage and disease symptoms in SLE patients.

While Saphnelo failed to meet its endpoints in its TULIP 1 Phase III trial, evaluation proved patients did have significant improvements such as lowered steroid intake and improvements in skin lupus effects. Lupus drug efficacy can be notoriously hard to prove. Trial goals were adjusted for TULIP-2 and it did meet its primary endpoint. Reduced disease activity was seen as early as two months into treatment.

“This approval represents a critical milestone for lupus research and an exciting new therapeutic option for patients with lupus,” said Dr. Mary Crow, a trailblazer of interferon research and former chair of the Lupus Research Alliance Scientific Advisory Board.

“It is personally gratifying to have discovered the activation of the type I interferon pathway as a significant mechanism in lupus disease and to see the fruition of interferon research and the related drug development program.”

The drug is currently under review for approval in the EU and Japan. Additional Phase III trials have been launched to test subcutaneous delivery and as treatment for lupus nephritis, cutaneous lupus erythematosus and myositis.

Mene Pangalos, executive vice president, BioPharmaceuticals Research and Development, 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.”

AstraZeneca had a win with the FDA last month as well with the approval for its glucose-lowering drug in 10- to 17-year-olds with type 2 diabetes. This is the first once-weekly injection approved for older children with the disease. The convenience and ease of use should help the drug fill the gap in treatment options for this age group.  

Meanwhile, the company plans to seek authorization in the second half of this year for its COVID-19 vaccine after delaying submission originally slated for this spring.

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