AstraZeneca PLC (LSE:AZN) has received EU approval for the first new drug in over a decade for people with systemic lupus erythematosus (SLE).
The disease occurs when the body’s own immune system attacks tissue and organs.
Saphnelo works by dampening the excessive type I interferon signature that is found in many patients.
It will be prescribed as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive lupus.
"Saphnelo is the first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade and is the only biologic not restricted to patients with a high degree of disease activity,” said Mene Pangalos, AZ’s head of biopharmaceutical research.
“Saphnelo has demonstrated clinically meaningful benefits and we look forward to bringing it to patients as quickly as possible.”
The Anglo-Swedish giant will pay royalties on sales in the low-to-mid teens per cent to Bristol Myers Squibb, which now owns Medarex, the company that originally discovered Saphnelo.