Anifrolumab (Saphnelo) Gets Green Light for Approval in EU

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 binds to subunit 1 of the type I interferon receptor and thereby blocks the biologic activity of type I interferons, was approved by the US Food and Drug Administration in July 2021.

The 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 with moderate or severe SLE activity at baseline.

The manufacturer AstraZeneca said the biologic drug will be available as a 300 mg concentrate for solution for infusion.

The most common adverse reactions are upper respiratory tract infection, bronchitis, infusion-related reaction, and herpes zoster. The most common serious adverse reaction was herpes zoster.

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