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), despite standard therapy, according to an announcement on Dec. 16.
Anifrolumab, a monoclonal antibody that is able to bind to subunit 1 of the type I interferon receptor and consequently blocks the biological action of type I interferons, was approved by the US Food and Drug Administration in July 2021.
The decision to prescribe anifrolumab is due to its ability to trigger a clinical response on the British Isles Lupus Assessment Group’s Composite Lupus Assessment (BICLA) at week 52 which is defined as improvement in all organ domains with moderate or severe SLE activity at baseline.
The company behind the product AstraZeneca has announced that the biologic drug will be available as a 300 mg concentrate to be used as an infusion solution.
The most frequent adverse reactions are upper respiratory infections and bronchitis. Infusion-related reactions are also common. herpes simplex is the most severe. The most frequent serious adverse reaction was herpes Zoster.
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