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托珠单抗用于治疗COVID-19重症患者在欧获批！
Actemra®/RoActemra® (tocilizumab) is a monoclonal antibody drug developed by Roche that targets the interleukin-6 receptor (IL-6 receptor). The drug is currently on the market in China for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA). Studies have shown that COVID-19 patients experienced rapid reductions in fever within days after receiving tocilizumab, with 75% of patients (15 out of 20) reducing their need for supplemental oxygen.
On December 7, 2021, Roche announced that the European Commission has expanded the marketing authorization of Actemra®/RoActemra® (tocilizumab) to include adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Levi, Chief Medical Officer and Head of Global Product Development, Roche Dr. Garraway said: "Actemra/RoActemra is Roche's second COVID-19 drug that has been rapidly approved by the European Commission in recent weeks. All evidence shows that Actemra/RoActemra can benefit patients with severe COVID-19. Europe and the world are facing new challenges in the COVID-19 pandemic, and Actemra/RoActemra, together with COVID-19 vaccines, other treatments and tests, form an important line of defense against the epidemic."
The European Commission’s decision follows an accelerated review by the EMA’s (European Medicines Agency) CHMP (Committee for Medicinal Products for Human Use), which reviewed the results of four studies using Actemra/RoActemra in more than 5,500 patients with severe or critical illness with COVID-19. These studies include the Roche-led Phase 3 COVACTA, EMPACTA and REMDACTA trials, and the Roche-supported Oxford Randomized Evaluation of COVID-19 Treatment (RECOVERY) study.
In addition to the EU, Actemra/RoActemra has received provisional approval in Australia and emergency use authorization in the United States and Ghana. The World Health Organization (WHO) also recommends the use of Actemra/RoActemra to treat COVID-19. Roche is working closely with regulatory authorities and other partners around the world to take the next steps to make this medicine available to more people.
The recent emergence of a new SARS-CoV-2 variant, Omicron (B.1.1.529, Omicron), has prompted the World Health Organization to state that interleukin-6 receptor blockers (e.g., Actemra/RoActemra) remain effective in managing patients with severe COVID-19.
References:
https://www.roche.com/media/releases/med-cor-2021-12-07.htm
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