VCBeat Health Contact Us
Home EU Approves Roche's Actemra/RoActemra (Tocilizumab) for Severe COVID-19 in Adults as Global Cases Surpass 270 Million

EU Approves Roche's Actemra/RoActemra (Tocilizumab) for Severe COVID-19 in Adults as Global Cases Surpass 270 Million

Dec 14, 2021 01:40 CST Updated 01:40
Roche

Oncology Drug Research, Development, and Manufacturing

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.


December 13, 2021 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，as of 21:00 on December 13, 2021, the global cumulativeConfirmed cases exceed 270 million (270.52 million), with more than 5,320,000 deaths.

Recently, Roche announced that the European Commission (EC) has approvedActemra/RoActemra (Chinese trade name: Yamiluo), Generic Name: Tocilizumab, (Trade Name: Actemra),For the treatment of adult patients with COVID-19 who are receiving systemic corticosteroids, require supplemental oxygen, or mechanical ventilation.

Actemra/RoActemra is the world's first humanized monoclonal antibody drug targeting the IL-6 receptor (IL-6R). It exerts anti-inflammatory effects by blocking IL-6 signaling through targeted binding to IL-6R. IL-6 is a multifunctional pro-inflammatory cytokine that plays a critical role in activating inflammatory pathways. In severe or critically ill patients with COVID-19, there exists an overly active inflammatory immune response.

This EU approval is based on the results of four Phase 3 clinical studies, involving more than 5,500 patients with severe or critical COVID-19. These include the Phase 3 COVACTA, EMPACTA, and REMDACTA trials led by Roche, as well as the RECOVERY trial conducted by the University of Oxford and supported by Roche.

Mechanism of Action of Tocilizumab

Outside the EU, Actemra/RoActemra has received provisional approval in Australia, Emergency Use Authorization (EUA) in the United States, and a recommendation from the World Health Organization (WHO) for the treatment of COVID-19. Roche is working closely with regulatory authorities and other partners around the world to take further steps to make Actemra/RoActemra available to as many people as possible.

Following the recent emergence of the new SARS-CoV-2 variant Omicron (B.1.1.529) that has drawn widespread attention, the WHO reported that interleukin-6 receptor (IL-6R) blockers, such as Actemra/RoActemra, are expected to remain effective in treating severe COVID-19 patients.

Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, stated: "Actemra/RoActemra is the second Roche drug to receive EU approval for treating COVID-19 in recent weeks. The overall evidence suggests that treatment with Actemra/RoActemra can benefit patients with severe COVID-19. As we face new challenges from the COVID-19 pandemic across Europe and globally,Actemra/RoActemra, combined with vaccines, other therapeutic agents, and testing, will form an essential barrier of care."

The active pharmaceutical ingredient of Actemra/RoActemra is tocilizumab, a recombinant humanized monoclonal antibody against the human interleukin-6 (IL-6) receptor, which belongs to the immunoglobulin IgG1 subtype. Tocilizumab binds to both 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 various physiological processes., is considered to be involved in the activation of classesRheumatoid Arthritis(RA) and other inflammatoryAutoimmuneInflammatory pathways play a key role in the symptoms and signs of sexual diseases. Tocilizumab blocks the pro-inflammatory effects of the IL-6 cytokine by binding to the IL-6 receptor.

As of now, Actemra/RoActemra has been approved for multiple indications, including: rheumatoidRheumatoid Arthritis(RA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA), cytokine release syndrome (CRS), Castleman disease, and Takayasu arteritis. Actemra/RoActemra is available in both intravenous (IV) and subcutaneous (SC) formulations, with specific indications varying by country and region. In China, the IV formulation of Actemra/RoActemra has been approved for the treatment of RA, sJIA, and CRS.

In March 2021, the US FDA approved a new indication for Actemra/RoActemra SC formulation: 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 US FDA for the treatment of SSc-ILD. SSc-ILD is alsoFDAThe sixth approved treatment indication for Actemra/RoActemra. (Bioon.com)