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FDA granted Roche Actemra/RoActemra emergency use for COVID-19 patients
FDA granted Roche Actemra/RoActemra emergency use for COVID-19 patients. The US FDA granted Roche’s anti-inflammatory drug Actemra/RoActemra emergency use authorization: treatment of COVID-19 hospitalized patients!
Recently, Roche announced that the U.S. Food and Drug Administration (FDA) has granted Actemra/RoActemra® (generic name: tocilizumab, tocilizumab) an emergency use authorization (EUA) for intravenous preparations. For the treatment of COVID-19 hospitalized adults and pediatric patients (2 years and older) who are receiving systemic corticosteroids and require supplemental oxygen/noninvasive or invasive ventilation/extracorporeal membrane oxygenation (ECMO).
Actemra/RoActemra® is the world’s first humanized monoclonal antibody drug targeting IL-6 receptor (IL-6R), which can block IL-6 signal transduction by targeting IL-6R to exert anti-inflammatory effects. IL-6 is a multifunctional pro-inflammatory cytokine, which is believed to play a key role in activating inflammatory pathways. In severe or critically ill patients with COVID-19, there is an overactive inflammatory immune response.
Tocilizumab mechanism of action
The EUA is based on the results of 4 randomized controlled studies. These studies evaluated the effectiveness of Actemra/RoActemra in the treatment of COVID-19 in more than 5,500 hospitalized patients. The RECOVERY study was led by British researchers and included more than 4,000 COVID-19 hospitalized patients. Roche-sponsored global trials include 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 found. The most common adverse reactions (incidence ≥ 3%) are constipation, anxiety, diarrhea, insomnia, hypertension, and nausea.
Roche Chief Medical Officer and Head of Global Product Development Levi Garraway, MD, said: “Even if vaccines are available all over the world and the number of deaths from COVID-19 is declining, we can still see new cases of hospitalizations due to serious illnesses. We are pleased that Actemra/RoActemra is now authorized as an option that may help improve the prognosis of adults and children hospitalized with COVID-19.”
The active pharmaceutical ingredient of Actemra/RoActemra is tocilizumab, which is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of immunoglobulin IgG1 subtype. Tocilizumab binds to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and inhibits signal transduction mediated by sIL-6R and mIL-6R. IL-6 is a multifunctional pro-inflammatory cytokine involved in a variety of physiological processes, and is believed to play a key role in activating the inflammatory pathways involved in the symptoms and signs of rheumatoid arthritis (RA) and other inflammatory autoimmune diseases effect. Tocilizumab blocks the pro-inflammatory effects of IL-6 cytokines by binding to IL-6 receptors.
Up to now, Actemra/RoActemra has been approved for multiple indications, including: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), Giant cell arteritis (GCA), cytokine release syndrome (CRS), Castleman disease, aortic arteritis. Actemra/RoActemra includes intravenous (IV) preparations and subcutaneous (SC) preparations, and the specific indications vary in different countries and regions. In China, Actemra/RoActemra IV preparations have been approved for the treatment of RA, sJIA, and CRS.
In March 2021, the US FDA approved a new indication for Actemra/RoActemra SC preparation: it is used to delay the decline of lung function in adult patients with systemic sclerosis-related interstitial lung disease (SSc-ILD). SSc-ILD is a debilitating disease and treatment options are very limited. It is worth mentioning that Actemra/RoActemra is the first biological therapy approved by the US FDA for the treatment of SSc-ILD. SSc-ILD is also the sixth Actemra/RoActemra treatment indication approved by the FDA.
(source:internet, reference only)