AstraZeneca’s Saphnelo (anifrolumab) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for approval in the European Union as a self-administered, once-weekly pre-filled pen for adults with systemic lupus erythematosus (SLE).
The decision is based on interim results from the phase 3 TULIP-SC trial, which demonstrated that subcutaneous administration of Saphnelo significantly reduced disease activity compared to placebo in patients with moderate to severe, active, autoantibody-positive SLE receiving standard therapy. The safety profile was consistent with that of the intravenous formulation.
Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, 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.”
He added: “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.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, explained: “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.”
