AstraZeneca plc (NASDAQ:AZN) has been granted approval by the U.S. Food and Drug Administration for a new self-injection format of SAPHNELO (anifrolumab-fnia), enabling adult patients with systemic lupus erythematosus (SLE) to administer the treatment once weekly at home alongside standard therapy.
The approval is based on results from the Phase III TULIP-SC trial, which found that subcutaneous use of SAPHNELO led to a statistically significant improvement in disease activity versus placebo in patients with moderate to severe SLE. The safety outcomes were consistent with those observed for the intravenous version of the drug.
The therapy will be available as a 120mg weekly dose delivered via the SAPHNELO Pen autoinjector or a pre-filled syringe, offering a more convenient alternative to the IV infusion that has been in use since 2021 in hospital and clinic settings.
Subcutaneous SAPHNELO has already secured approval in the European Union and Japan, while reviews are ongoing in other regions. The intravenous formulation is approved in over 70 countries worldwide for treating moderate to severe SLE, with more than 40,000 patients having received the therapy to date.
The TULIP-SC study was a global Phase III, randomised, double-blind, placebo-controlled trial involving 367 participants aged 18 to 70 with moderate to severe SLE. Patients were randomly assigned to receive either a 120mg subcutaneous dose of anifrolumab or placebo using a single-use pre-filled syringe.
SAPHNELO is a fully human monoclonal antibody that targets the type I interferon receptor subunit 1, blocking interferon activity. Under an updated agreement with Bristol-Myers Squibb (NYSE:BMY), AstraZeneca will pay a mid-teens royalty on U.S. sales of the treatment.