How lupus clinical trials are evolving

A high magnification micrograph of histomorphologic changes in a lymph node resulting from systemic lupus erythematosus (SLE). Image from Wikipedia.

In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities.

Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). SLE is the most common form of lupus. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society.

A fully human monoclonal antibody, anifrolumab binds to subunit 1 of the type I interferon receptor, potentially calming the impact of pro-inflammatory cytokines involved in lupus.

Anifrolumab has shown promise in SLE patie…

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