AstraZeneca gets FDA nod for Saphnelo

The Food and Drug Administration has approved AstraZeneca's Saphnelo (anifrolumab-fnia) as a treatment for adults with systemic lupus erythematosus who are receiving standard therapy.

It is the third FDA approval of a lupus therapy since 2011, expanding treatment options for this medically underserved and life-threatening autoimmune disease.

Saphnelo is a monoclonal antibody administered by intravenous infusion.  Saphnelo inhibits a key protein in the immune system called the IFNAR receptor that acts as a transmitter, amplifying signals from tiny messengers called type I interferons. This process activates many parts of the immune system and can trigger major inflammation. Saphnelo dampens the excessive type I interferon signature found in up to 80% of adults with lupus and as many as 90% of children with the disease.

 "After having only one therapy approved for lupus during the past 60 years, it is a cause for celebration to have two new treatment options approved in 2021 alone for this life-threatening autoimmune disease that affects an estimated 1.5 million Americans," said Stevan Gibson, president and CEO, Lupus Foundation of America. "The pipeline of potential new treatments for lupus remains vibrant, and the Lupus Foundation of America continues its work to bring down barriers to lupus drug development and ensure that people with lupus will have access to the medications they need to improve their quality of life."