The U.S. Food and Drug Administration approved AstraZeneca's SAPHNELO (anifrolumab-fnia) for self-administration as a once-weekly autoinjector for treating adult patients with systemic lupus erythematosus alongside standard therapy.

The approval was based on results from the Phase III TULIP-SC trial, which demonstrated that subcutaneous administration of SAPHNELO led to a statistically significant reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. The safety profile observed was consistent with the known clinical profile of SAPHNELO administered as an intravenous infusion.

SAPHNELO will be available for subcutaneous self-administration via a once-weekly 120mg autoinjector called the SAPHNELO Pen or a pre-filled syringe. The drug has been available since 2021 as an IV infusion administered by healthcare professionals in hospital or clinic settings.

Subcutaneous administration of SAPHNELO is approved in the European Union and Japan and is under regulatory review in several other countries. SAPHNELO IV infusion is approved for treating moderate to severe SLE in more than 70 countries worldwide. More than 40,000 patients globally have been treated with SAPHNELO to date.

The TULIP-SC trial was a Phase III, multicenter, randomized, double-blind, placebo-controlled study involving 367 participants aged 18 to 70 years with moderate to severe SLE. Participants were randomized 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo via a pre-filled, single-use syringe.

SAPHNELO is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor, blocking the activity of type I IFN. Under an updated agreement with Bristol-Myers Squibb, AstraZeneca (LSE/STO/NYSE: AZN) will pay a mid-teens royalty for U.S. sales.