20th Oct 2025 08:49
(Alliance News) - AstraZeneca PLC on Monday said its lupus drug Saphnelo received a positive opinion from the European Medicines Agency's committee for medicinal products for human use for a new subcutaneous formulation.
The once-weekly self-administered injection is intended for adults with autoimmune disease systemic lupus erythematosus on top of standard therapy.
The recommendation is based on phase III trial data showing significant reductions in disease activity versus placebo, with a safety profile consistent with the intravenous version.
Ruud Dobber, executive vice president of the BioPharmaceuticals business unit, said the decision brings AstraZeneca "one step closer to offering the clinically meaningful benefits of Saphnelo to more people in a convenient, once-weekly self-administration option".
Systemic lupus erythematosus is an autoimmune condition affecting over 3.4 million people globally. It mostly strikes women and can cause pain, rashes, fatigue, swelling in joints and fevers.
Separately, AstraZeneca said the US Food & Drug Administration has approved Tezspire, developed in partnership with Amgen Inc, for the add-on maintenance treatment of adults and adolescents aged 12 and over with inadequately controlled chronic rhinosinusitis with nasal polyps.
Dobber said the approval "expands the reach of this innovative treatment option" and reinforces Tezspire's potential to address multiple epithelial-driven inflammatory diseases.
Inadequately controlled chronic rhinosinusitis with nasal polyps affects up to 320 million people worldwide, with affected people commonly experiencing airflow obstruction, congestion and an impaired sense of smell.
AstraZeneca shares were up 0.2% at 12,588.00 pence each on Monday morning in London.
By Tom Budszus, Alliance News slot editor
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