AstraZeneca plc (LSE:AZN) has received approval from the U.S. Food and Drug Administration for a new self-administered version of SAPHNELO (anifrolumab-fnia), allowing adult patients with systemic lupus erythematosus (SLE) to use a once-weekly autoinjector alongside standard therapy.
The decision is supported by findings from the Phase III TULIP-SC study, which showed that subcutaneous delivery of SAPHNELO significantly reduced disease activity compared to placebo in patients with moderate to severe SLE who were also receiving standard treatment. The safety profile aligned with that already established for the intravenous formulation.
The treatment will now be offered as a 120mg weekly dose via the SAPHNELO Pen autoinjector or a pre-filled syringe for at-home use. Since 2021, SAPHNELO has been available as an intravenous infusion administered by healthcare professionals in clinical settings.
Subcutaneous use of SAPHNELO has already been approved in the European Union and Japan, and regulatory reviews are ongoing in several other markets. The intravenous formulation is currently authorised in more than 70 countries for moderate to severe SLE, with over 40,000 patients treated worldwide.
The TULIP-SC trial was a Phase III, multicentre, randomised, double-blind, placebo-controlled study involving 367 patients aged between 18 and 70 with moderate to severe SLE. Participants were evenly assigned to receive either a 120mg subcutaneous dose of anifrolumab or a placebo using a single-use pre-filled syringe.
SAPHNELO is a fully human monoclonal antibody that targets subunit 1 of the type I interferon receptor, inhibiting type I interferon activity. Under a revised agreement with Bristol-Myers Squibb (NYSE:BMY), AstraZeneca will pay a mid-teens royalty on U.S. sales of the drug.
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