AstraZeneca' Saphnelo Wins FDA Nod For Systemic Lupus Erythematosus, Marking New Treatment Approval In 10 Years

The FDA has approved AstraZeneca Plc's AZN Saphnelo (anifrolumab-fnia) for adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.
The approval was based on efficacy and safety data from the development program, including two TULIP Phase 3 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, with both groups receiving standard therapy.
This marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist and the only new treatment approved for SLE in more than a decade.
Type I IFN plays a central role in the pathophysiology of lupus, and increased type I IFN signaling is associated with increased disease activity and severity.
Saphnelo is under regulatory review for SLE in the EU and Japan.
AstraZeneca will pay Bristol-Myers Squibb Co. BMY a low to mid-teens royalty for sales dependent on geography.
Price Action: AZN shares are down 0.28% at $57.08 during the premarket session on the last check Monday, while BMY closed Friday's session at $67.87.
Related content: Benzinga's Full FDA Calendar.