AstraZeneca Saphnelo US FDA Approval

AstraZeneca's drug Anifrolumab (anifrolumab) has received approval from the United States — Food and Drug Administration for self-administration via a once-weekly autoinjector, the Anifrolumab Pen, for adult patients with moderate to severe Lupus. This approval is based on positive results from the Phase III TULIP-SC trial, which demonstrated a significant reduction in disease activity. The new self-administration option offers greater flexibility and convenience for patients, expanding Anifrolumab's clinical benefits and market reach. AstraZeneca acquired the global rights to Anifrolumab from Medarex in 2004, and under an updated 2025 agreement, will pay Bristol Myers Squibb (which acquired Medarex in 2009) a royalty on US sales.