Anifrolumab
Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus (SLE). It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β. Anifrolumab was approved for medical use in the United States in July 2021. Adverse effects. The most common adverse effect was shingles, which occurred in 5% of patients in the low-dose group, to 10% in the high-dose group, and to 2% in the placebo group. Overall adverse effect rates were comparable in all groups. History . The drug was developed by MedImmune, a unit of AstraZeneca, which chose to move anifrolumab instead of sifalimumab into phase III trials for lupus in 2015. Clinical trial results. Anifrolumab failed to meet its endpoint of significant reduction in disease as assessed by the SLE Responder Index 4 instrument in the TULIP 1 phase III trial. This multi-center, double-blind, placebo-controlled study followed adults with moderate to severe SLE over the course of one year. Preliminary results were announced on 31 August 2018. Society and culture. Legal status. On 16 December 2021, the Committee for Medicinal Products for  Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Saphnelo, intended for the treatment of moderate to severe systemic lupus erythematosus (SLE). The applicant for this medicinal product is AstraZeneca AB. Anifrolumab was approved for medical use in the European Union in February 2022. Names. Anifrolumab is the international nonproprietary name (INN).