In June 2021, the Ministry of Health of the Russian Federation has approved pathogenetic therapy of cytokine release syndrome in patients with moderate to severe new coronavirus infection (COVID-19) as an additional indication to be included in the olokizumab SmPC.
New coronavirus infection is characterized by systemic hyper-inflammation with elevated inflammatory cytokines, damaging the body’s own tissues and organs — a condition known as a “cytokine storm”, which has been recognized as a leading cause of severity COVID-19. Many clinical evidences have indicated the importance of anti-inflammatory immunomodulation therapy in severe COVID-19 with anti-IL6 monoclonal antibodies.
According to Nature Reviews Immunology, biological drugs that prevent IL-6 binding to IL-6R typically trap IL-6 in circulation and increase the systemic concentration of IL-6. This issue is less problematic with therapies such as olokizumab that target IL-6 to prevent the docking of IL-6 and IL-6R into a functional receptor complex with gp130. IL-6 antagonists may be beneficial when rapidly deployed in patients with severe COVID-19 and may have added benefits for patients with long COVID or recovering from chronic infectious diseases.
Olokizumab is the first IL-6 inhibitor available in Russia that blocks the cytokine rather than its receptor to be approved by the Ministry of Health of the Russian Federation for treatment of patients with new coronavirus infection. The drug was introduced into clinical practice of monoclonal antibodies to inhibit the activity of IL-6 and prevent COVID-19-associated systemic inflammation and hypoxic respiratory failure.
In May 2020, olokizumab received a market authorization from the Ministry of Health of the Russian Federation. Since June 2020, olokizumab has been included in the provisional COVID-19 treatment guidelines in Russia and became one of the first medications for the treatment of moderate coronavirus infection in the world. On October 14, 2020, the Ministry of Health of the Russian Federation included the drug in the List of Vital and Essential Medicines.
Approval for a new indication will help healthcare professionals make streamlined decisions to administer preemptive anticytokine therapy, contributing significantly to the overall treatment success.