Category: Casirivimab
Shots: The P-III trial evaluates REGEN-COV (1200mg, SC) vs PBO in a ratio (1:1) in patients who lived in the same household with COVID-19 patients diagnosed within the prior 4 days. The trial is jointly run with NIAID The results showed an 81.6% reduction in risk of COVID-19 during a pre-specified follow-up period b/w 2-8mos. […]
Shots: The P-III trial evaluates the efficacy and safety of REGEN-COV (casirivimab and imdevimab, 1200/2400mg) vs PBO in a non-hospitalized patient with COVID-19 The trial met its 1EPs & 2EPs i.e., 70% reduction in the risk of hospitalization or death in high-risk non-hospitalized patients & the safety profile was consistent with a previously reported data […]
Shots: The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19 The results showed a reduction in the risk of hospitalization or death by 70% in addition to the results from a P-I trial that demonstrated the safety, tolerability & PK in Japanese […]
Shots: The P-III RECOVERY trial evaluating REGEN-COV (8,000 mg) vs usual care alone in seronegative patients with COVID-19 demonstrates 20% reduction in risk of death in patients failing to exhibit a natural antibody response The 1EPs showed 20% reduction in all-cause mortality, no longer significant effect on 28-day mortality on combining larger seropositive group (also […]
Date: June 28, 2021 Issue #: 1627 Summary: The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 […]
Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its 1EP and 2EPs showed an 81% reduction in the risk […]
Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19 The CHMP scientific opinion supports national decision making within EU states on the use of the antibodies, prior to the future […]
Shots: Roche confirms that the US govt. will purchase additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed The agreement additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed. The cocktail has received the US FDA’s EUA […]
Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the […]
Shots: Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors The collaboration b/w Wilson and Penn’s GTP and Regeneron will have two phases. The first phase will include the validation of the effectiveness of Abs delivered via AAV in a large animal model […]
Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 The EUA […]