On June 11, 2020, Biocad announced that the Ministry of Health of the Russian Federation registered levilimab (trade name Ilsira) for patients with severe COVID-19. Developed by Biocad, levilimab is a human monoclonal antibody targeting membrane-bound and soluble forms of the interleukin 6 receptor. It was originally developed for treatment of rheumatoid arthritis. Levilimab received state approval for COVID-19 on June 5, 2020 through a fast-track mechanism according to Decree No. 441 of the Government of the Russian Federation, effective as of April 4, 2020.
The efficacy and safety of levilimab (BCD-089) in patients with severe COVID-19 is being evaluated in a Phase 3 multicenter, randomized, double-blind, placebo-controlled, adaptively designed clinical trial (NCT04397562). Initiated on April 24, 2020, the study includes 204 participants who received a single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy. According to Biocad, the results of a clinical trial of the drug demonstrate that levilimab therapy can significantly reduce mortality among patients with COVID-19.