The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for anifrolumab (Saphnelo) as an add-on treatment for adults with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), along with standard therapy, according to an announcement on Dec. 16. Anifrolumab acts against SLE, an autoimmune disorder characterized by antibodies to nuclear and cytoplasmic antigens and multisystem inflammation, as the monoclonal antibody that binds to subunit 1 of the type I interferon receptor and thereby blocks the biologic activity of type I interferons. The biological drug, developed by Astrazeneca, was approved by the US FDA in July. The CHMP 

recommendation for anifrolumab is based on its ability to elicit a clinical response on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52, which is defined as improvement in all organ domains.