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June 2021

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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Updates in the Treatment and Prevention of COVID-19​

Molnupiravir, an Oral Antiviral, Reduced the Risk of Hospitalization or Death in Patients with Mild-to-Moderate COVID-19

Molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death by 50% in an interim analysis of the phase 3 MOVe-OUT trial. The planned analysis evaluated data from 775 at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19. All patients enrolled had at least one risk factor associated with poor COVID-19 outcomes and were randomized within 5 days of symptom onset. At day 29, 7.3% of patients who received molnupiravir were either hospitalized or died, compared with 14.1% of placebo-treated patients (P= .0012). No deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Discontinuation due to adverse events was lower with molnupiravir (1.3%) versus placebo (3.4%).

Reference:

https://www.contagionlive.com/view/molnupiravir-could-become-first-authorized-covid-19-pill