The Ministry of Health of the Russian Federation has approved the original drug Levilimab (Russian trade name Ilsira) for the treatment of rheumatoid arthritis (RA) and extended the current list of its therapeutic indications.
Levilimab is an anti-interleukin-6 receptor (anti-IL-6R) monoclonal antibody, that was developed by the Russian biotechnology company BIOCAD. Ten years passed since the initial idea of creating the drug, the early stages of its development, its non-clinical and clinical studies and the launch. The full production cycle is carried out in Russia, so it is not dependent on imports and widely available for patients with rheumatoid arthritis.
The clinical development program and the possibility of further clinical use of levilimab for the treatment of rheumatoid arthritis were reviewed at a meeting of the Specialist Commission of the Expert Council of the Ministry of Health of the Russian Federation in the Field of Rheumatology on May 29, 2021. The Specialist Commission of the Expert Council stated that «following approval of the use of levilimab by the Ministry of Health of Russia, its inclusion in the clinical guidelines should be considered».
Dmitry Sivokoz, Vice President for Marketing, Sales and Market Access at the BIOCAD biotechnology company, says:
Rheumatoid arthritis is a systemic autoimmune disorder that is three times more common in female than in male patients. The disease is most common in working-age socially active patients (35-55 years), and results in early disability unless adequate biological therapy is initiated in a timely manner. Currently, no more than 5.6% of patients with rheumatoid arthritis receive genetically engineered biological drugs (GEBDs). Levilimab is an original product, an IL-6 receptor inhibitor, which, if prescribed in a timely manner, helps to stop the progression of rheumatoid arthritis and avoid disability.
Up to 30% of patients with confirmed rheumatoid arthritis require the use of GEBD due to a lack of response to other treatment methods.
Clinical studies of levilimab in patients with rheumatoid arthritis in Russia were initiated by BIOCAD in 2016. At the very beginning of the COVID-19 pandemic in April 2020, a phase 3 clinical study to evaluate therapy with levilimab in patients with severe COVID-19 was conducted. In June 2020, it became the first IL-6RA approved for the treatment of complicated COVID-19. In accordance with the approved temporary guidelines of the Ministry of Health of the Russian Federation for the «Prevention, diagnosis and treatment of COVID-19» and the summary of product characteristics of levilimab, it is indicated for patients with moderate to severe COVID-19 to prevent the development of life-threatening conditions. The drug was included in the List of Vital and Essential Medicines in 2020.
The application for registration of levilimab on the international markets is being prepared.