bamlanivimab

An EUA for Sotrovimab for Treatment of COVID-19

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 …

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Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID

Shots: The P-II BLAZE-4 study involves assessing bamlanivimab as monothx. and bamlanivimab (700mg) + VIR-7831 (500mg) vs PBO in 1000 participants with symptomatic low-risk COVID-19 in the outpatient setting across the US and Puerto Rico Results: The dual regimen met its 1EPs i.e. 70% relative reduction in persistently high viral load (> 5.27; cycle threshold …

Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID Read More »

Elli Lilly Reports Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) in P-III BLAZE-1 Study for the Prevention of COVID-19

Shots: The P-III BLAZE-1 study involves assessing Bamlanivimab (700 mg) + Etesevimab (1400 mg) vs PBO in 769 COVID-19 patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 and/or hospitalization The results demonstrated an 87% reduction in hospitalizations and death with significant improvements in 2EPs The data support the use of …

Elli Lilly Reports Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) in P-III BLAZE-1 Study for the Prevention of COVID-19 Read More »

EMA backs emergency use of Lilly’s COVID antibodies

The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The CHMP says bamlanivimab (LY-CoV555) can be given alone or administered together with etesevimab (LY-CoV016) to treat at-risk patients aged 12 …

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Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19

Shots: The P-II/III BLAZE-1 trial involves assessing of Bamlanivimab + Etesevimab (2800 mg) vs PBO in 1035 patients recently diagnosed with COVID-19 in the ambulatory setting The results demonstrated an 70% reduction in risk of COVID-19 related hospitalizations and deaths in high-risk patients and improvements in all 2EPs including reductions in viral load and accelerated …

Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19 Read More »

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Shots: The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention & in exploratory analyses respectively The results demonstrated an 80% reduction …

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes Read More »

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are …

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19 Read More »

Lilly to ship COVID-19 drug straight away after FDA green light

Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older, who are at high risk for progressing to severe disease …

Lilly to ship COVID-19 drug straight away after FDA green light Read More »

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Shots: The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the treatment of symptomatic COVID-19 in the outpatient setting. The EUA is granted for bamlanivimab (LY-CoV555, 700 mg) Patients showed reduced viral load & rates of symptoms & hospitalization. The EUA …

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19 Read More »

Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior to drug infusion Results: The study showed that bamlanivimab may …

Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine Read More »

US buys Lilly COVID antibody, as effectiveness questions remain

The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation (EUA) – despite the fact its effectiveness has been called into question. The initial agreement is for delivery over the two months following an EUA, and provides the option for …

US buys Lilly COVID antibody, as effectiveness questions remain Read More »

Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data

The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.