AstraZeneca has reported that its antibody Saphnelo (anifrolumab) obtained approval in the EU as an add-on therapy for the treatment of adults with moderate-to-severe, active autoantibody-positive systemic lupus erythematosus (SLE).
Saphnelo is indicated to treat SLE in patients who already received standard therapy.
With the latest approval, Saphnelo became the first SLE treatment to receive approval in Europe with an indication not limited to use in patients with increased disease activity.
A fully human monoclonal antibody, Saphnelo attaches to subunit 1 of the type I IFN receptor, hindering type I interferons’ (IFNs) activity.
The approval is based on data from the clinical development programme of Saphnelo, including the Phase III TULIP clinical trials and the Phase II MUSE trial.
Trial findings showed that subjects who received Saphnelo had a decline in overall disease activity across organ systems and also attained sustained decline in the usage of oral corticosteroid (OCS) versus placebo.
Cutting down the use of OCS while lowering disease activity is a key treatment goal in SLE to lessen organ damage risk, the company noted.
The latest development comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorisation in the EU in December last year.
Upper respiratory tract infection, bronchitis, reactions associated with infusion and herpes zoster were the most common adverse reactions reported in subjects treated with Saphnelo in the controlled trials.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.
“Saphnelo has demonstrated clinically meaningful benefits and we look forward to bringing it to patients as quickly as possible.”
In 2004, AstraZeneca and Medarex entered an exclusive licence and partnership agreement under which the former gained international rights to Saphnelo.
Earlier, AstraZeneca reported total revenue of $37.42bn for the full year 2021.