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EUA Granted for Monoclonal Antibody for Hospitalized People With COVID-19

The monoclonal antibody, tocilizumab, blocks the interleukin-6 (IL-6) receptor and reduces inflammation caused by an overactive immune reaction to COVID-19. It was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) on June 24, 2021. The EUA applies to adults and pediatric patients hospitalized with COVID-19 and who are receiving systemic …

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SARS-CoV-2 Delta Variant and Its Effect on Current Prevention and Treatment Strategies

The SARS-CoV-2 Delta variant (B.1.617.2) that first emerged in India is now the most prevalent Variant of Concern (VOC) in the United Kingdom1 and has been detected in almost 10% of all infections in the United States.2 Delta appears to be more transmissible than the Alpha variant (B.1.1.7)1 and carries mutations L452R and K478T in …

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Emergency Use Authorization for Lower Dose Intravenous and Subcutaneous Casirivimab Plus Imdevimab

On June 4, 2021, the dose of casirivimab and imdevimab monoclonal antibody cocktail authorized by the Food and Drug Administration (FDA) was lowered from 2400 mg to 1200 mg—600 mg of each agent administered as a single infusion or injection. This antibody combination is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric …

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New COVID-19 Monoclonal Antibody Granted Emergency Use Authorization

On May 26, 2021, a new COVID-19 monoclonal antibody therapy—sotrovimab (previously VIR-7831)— was added to the list of infusion therapies authorized by the Food and Drug Administration for non-hospitalized people 12 years of age and older and weighing at least 40 kg, who have mild-to-moderate COVID-19 and risk factors for progressing to severe disease.1 Rather …

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Research Aimed at Understanding Long COVID

Infection with severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, can leave persistent and prolonged effects in multiple organ systems, causing breathing problems, fatigue, joint pain, brain fog, and heart palpitations, plus depression and other mood disorders.1,2 Survivors of the SARS epidemic and the Middle East respiratory syndrome, or MERS, outbreak have reported similar long-term …

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Therapies For COVID-19 Prevention

Other than vaccines, there are currently no therapies approved or authorized for emergency use for prevention of COVID-19. At the beginning of the pandemic, there was a lot of buzz around hydroxychloroquine as a preventive agent for both pre-exposure prophylaxis among healthcare workers and post-exposure prophylaxis for healthy household contacts; however, clinical trials to date …

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COVID-19 Monoclonal Antibodies and Effectiveness Against Variants

The Centers for Disease Control and Prevention (CDC) report that the COVID-19 variant first identified in the U.K.—B.1.1.7—is the most common cause of new infection in the U.S, particularly in Florida, Michigan, Minnesota, Massachusetts, Colorado, California, Maryland, Pennsylvania, and New Jersey.1 This strain has evidence of being more infectious and causing more severe disease compared …

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Messenger RNA Vaccines Against COVID-19 and its Variants

The novel messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) carry the genetic code the host cell needs to make the surface spike protein antigen to closely mimic a natural infection.1 To study the effectiveness of these vaccines, the US Centers for Disease Control and Prevention (CDC) conducted a longitudinal real-world study …

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Coronavirus Variants and their Impact on Treatment

New coronavirus variants are circulating in the United States. The Department of Health and Human Services (HHS) established a SARS-CoV-2 interagency group (SIG) to improve coordination among government agencies in characterizing and monitoring new variants and determining their potential impact on COVID-19 treatment and prevention measures. The SIG includes the Centers for Disease Control and …

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Updates in the Treatment and Prevention of COVID-19​

Casirivimab and Imdevimab Approved in Japan for the Treatment of Mild-to-Moderate COVID-19

Japan’s Ministry of Health, Labour and Welfare (MHLW) has fully approved the combination of casirivimab and imdevimab to treat patients with mild-to-moderate COVID-19. This marks the first time a monoclonal-antibody cocktail has received full approval to treat COVID-19. This combination therapy is currently authorized for emergency use in more than 20 countries, including the United States, European Union, India, Switzerland, and Canada. The monoclonal antibody cocktail was approved in Japan after results from a phase 3 trial showed a 70% reduction in the risk of hospitalization or death in high-risk non-hospitalized patients who received casirivimab and imdevimab. The MHLW also reviewed results from a phase 1 trial that analyzed the safety, tolerability, and pharmacokinetics of the combination therapy in Japanese subjects. Multiple analyses have shown that casirivimab and imdevimab retain potency against circulating variants of concern, including Delta (B.1.162.2, first seen in India), Gamma (P.1, first seen in Brazil), and Beta (B.1.351, first seen in South Africa).

Reference

https://newsroom.regeneron.com/news-releases/news-release-details/japan-becomes-first-country-approve-regeneron-antibody-cocktail