CHMP Recommends Approval Of AstraZeneca’s Self-Injectable Saphnelo For Systemic Lupus Erythematosus

AstraZeneca’s Saphnelo® (anifrolumab) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for approval in the European Union (EU) as a self-administered, once-weekly pre-filled pen for adult patients with systemic lupus erythematosus (SLE) receiving standard therapy.

Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, Germany and investigator of the TULIP-SC trial said: “The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment. With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimising steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients.”

The recommendation is supported by interim results from the Phase III TULIP-SC trial, which demonstrated that subcutaneous (SC) Saphnelo significantly reduced disease activity compared to placebo in patients with moderate to severe, active, autoantibody-positive SLE on background standard-of-care therapy. The safety profile of the SC formulation was consistent with that of the approved intravenous (IV) infusion, confirming its tolerability.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Saphnelo IV infusion has already helped transform outcomes for many patients with systemic lupus erythematosus. 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. 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.”

SLE is a chronic autoimmune disease affecting over 3.4 million people globally, primarily women, and is associated with pain, fatigue, and multi-organ inflammation. While corticosteroids are commonly used, they carry notable side effects and do not address the root causes of the disease. With many patients already preferring subcutaneous biologic treatments, this new option offers greater convenience and autonomy. Subcutaneous Saphnelo is also under regulatory review globally, while the IV formulation is already approved in more than 70 countries, including the US, EU, and Japan, and has been used to treat over 40,000 patients worldwide.