AstraZeneca (LON:AZN) has won FDA approval for Saphnelo (anifrolumab-fnia) to treat moderate to severe systemic lupus erythematosus (SLE) in adults.
The drug is the first treatment for SLE to win FDA approval in more than one decade.
Saphnelo targets the type I interferon (IFN) pathway, which plays a role in the pathophysiology of lupus. Researchers have linked elevated levels of type I IFN signaling with increased disease activity and severity.
“We have known since the 1970s that interferons were involved with lupus,” said Dr. George Tsokos, a member of the Lupus Foundation of America Medical-Scientific Advisory Council, in a statement. “With the approval of Saphnelo, we now have one more drug that allows us to translate valuable research knowledge into clinical practice with multiple benefits for our patients with lupus.”
In approving the drug, FDA considered data from two TULIP Phase 3 trials and the MUSE Phase 2 trial.
Across those stud…