Roche’s Actemra/RoActemra Receives FDA Emergency Use Authorization for Hospitalized COVID-19 Patients Amid Global Cases Surpassing 181 Million

June 26, 2021 /BioonBIOON/ -- According to Baidu's 《Real-time Novel Coronavirus Pneumonia EpidemicBig Data"Report", as of 22:00 on June 26, 2021,Global cumulative confirmed cases exceeded 180 million (181.27 million), with deaths surpassing 3.92 million.

Recently, Roche announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the intravenous formulation of Actemra/RoActemra® (Chinese brand name: Yanmeiluo®, generic name: tocilizumab) for the treatment of hospitalized adult and pediatric patients (2 years of age and older) with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Actemra/RoActemra® is the world’s first humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R), which exerts anti-inflammatory effects by specifically binding to IL-6R to block IL-6 signaling. IL-6 is a multifunctional pro-inflammatory cytokine believed to play a key role in activating inflammatory pathways.In patients with severe or critical COVID-19, a hyperactive inflammatory immune response is present.

Mechanism of Action of Tocilizumab

This EUA is based on the results of four randomized controlled trials. These trials evaluated the efficacy of Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The RECOVERY trial, led by UK researchers, enrolled over 4,000 hospitalized patients with COVID-19. The global trials sponsored by Roche include the placebo-controlled EMPACTA, COVACTA, and REMDACTA studies.

The results of these studies indicate that,Actemra/RoActemra can improve the prognosis of patients receiving corticosteroids and requiring supplemental oxygen or respiratory support.In these studies, no new safety signals for Actemra/RoActemra were identified. The most commonAdverse Reactions(Incidence ≥ 3%) were constipation, anxiety, diarrhea, insomnia,Hypertensionand nausea.

Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development at Roche, stated: “Even with vaccines available worldwide and COVID-19-related deaths declining, we continue to see new hospitalizations due to severe disease. We are pleased that Actemra/RoActemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19.”

The active pharmaceutical ingredient of Actemra/RoActemra is tocilizumab, a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1 subclass. Tocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R- and mIL-6R-mediated signal transduction. IL-6 is a pleiotropic pro-inflammatory cytokine involved in various physiological processes and is believed to be involved in activating...Rheumatic arthritis(RA) and other inflammatoryAutoimmunityplays a key role in the inflammatory pathways underlying the symptoms and signs of the disease. Tocilizumab binds to the IL-6 receptor, thereby blocking the pro-inflammatory effects of the IL-6 cytokine.

To date, Actemra/RoActemra has been approved for multiple indications, including:Rheumatic arthritis(RA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA), cytokine release syndrome (CRS), Castleman disease, Takayasu arteritis. Actemra/RoActemra includes intravenous (IV) and subcutaneous (SC) formulations, with specific indications varying across different countries and regions. In China, the Actemra/RoActemra IV formulation has been approved for the treatment of RA, sJIA, and CRS.

In March 2021, the U.S. FDA approved a new indication for the subcutaneous (SC) formulation of Actemra/RoActemra: to slow the rate of decline in lung function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). SSc-ILD is a debilitating disease with very limited treatment options. Notably, Actemra/RoActemra is the first biologic therapy approved by the U.S. FDA for the treatment of SSc-ILD. SSc-ILD is alsoFDAThe 6th approved indication for Actemra/RoActemra. (Bioon.com)

Original Source:Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children