AstraZeneca lupus treatment gets EU approval
By Benjamin Chiou
Date: Monday 20 Oct 2025
(Sharecast News) - AstraZeneca has received the green light from European regulators for its Saphnelo treatment for lupus, the pharma giant announced on Monday.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended Saphnelo for approval as a self-administered, once-weekly pre-filled pen for adult patients with systemic lupus erythematosus on top of standard therapy, the pharma company announced on Tuesday.
The development follows positive results from a phrase III trial which showed that subcutaneous administration of Saphnelo led to a "statistically significant and clinically meaningful reduction in disease activity" compared to a placebo.
Saphnelo, otherwise known as anifrolumab, is a monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN - a cytokine involved in regulating the inflammatory pathways implicated in SLE.
Ruud Dobber, executive vice president of AstraZeneca's BioPharmaceuticals Business Unit, said: "With this positive CHMP recommendation, we're one step closer to offering the clinically meaningful benefits of Saphnelo to more people in a convenient, once-weekly self-administration option."
He added: "We are also advancing a robust development programme to explore Saphnelo's potential in other diseases where type 1 interferon plays a central role, including cutaneous lupus erythematosus, lupus nephritis, myositis and systemic sclerosis."
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