- AstraZeneca
- 20 October 2025 07:26:21
Source: Sharecast
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."