According to an announcement on 16 December, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended anifrolumab (Safanelo) as an add-on treatment for adults with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE) despite standard therapy. Marketing authorization recommended.
Anifrolumab, a monoclonal antibody that binds to subunit 1 of the I interferon receptor and thus inhibits the biological activity of I interferon, was approved by the US Food and Drug Administration in July 2021.
Recommendation of anifrolumab is based on the ability to achieve clinical response on the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52, as an improvement in all organ domains with moderate or severe SLE activity at baseline. is defined in. ,
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.