AstraZeneca’s Evusheld (tixagevimab Y cilgavimabformerly AZD7442), a combination of long-acting antibodies, is approved in the European Union (EU) for the treatment of adults and adolescents (12 years and over, weighing at least 40 kg) with COVID-19. people who do not require supplemental oxygen and are at higher risk of progressing to severe COVID-19.
The European Commission’s approval is based on the results of the Phase III treatment trial against COVID-19 TACKLE showing the following. intramuscular dose The combination of antibodies (IM) provides clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo. Treatment with tixagevimab and silgavimab in the early stages of the disease has led to more favorable outcomes. TACKLE was performed in non-hospitalized adults with mild to moderate COVID-19 who were symptomatic for seven days or less. 90% of trial participants were at risk of progressing to severe COVID19 due to comorbidities or age. The antibody combination was generally well tolerated in the trial.
in his words Rick Suarez “We are very proud to continue to play an important role in the fight against COVID-19,” said the President of AstraZeneca in Spain. With this approval, Evusheld will become a new and effective option to protect infected patients at high risk of complications from the disease. At AstraZeneca, we will continue to work and collaborate with governments and institutions around the world to protect the world’s population and prevent hospitalizations and deaths from COVID-19.”
Teacher Michael Goldman The Université Libre de Bruxelles of the Interdisciplinary Institute for Innovation in Health and the former executive director of the European Initiative for Innovative Medicines says: “Many people are at high risk, including those who are immunocompromised, older adults and those with underlying health conditions. hospitalization and death if infected. This combination of intramuscularly administered antibodies is now a much-needed new COVID-19 treatment option for these vulnerable populations.”
Iskra ReichThe Executive Vice President of Vaccines and Immunotherapies at AstraZeneca emphasizes: “COVID-19 remains a health concern for millions of people in Europe and around the world, especially for those who are not well protected against the virus by vaccination. However, Confirmation is our long-acting antibody combination. It can now be used in Europe for both prevention and treatment of COVID-19, allowing us to protect more people from this devastating disease.”
Recommended dose for the treatment of COVID-19 in Europe 300 mg of tixagevimab and 300 mg of cilgavimabIt is administered as two separate sequential IM injections.
The antibody combination has been shown to preserve in vitro neutralization of Omicron BA.5, which is now the dominant variant of SARS-CoV-2 in Europe. 2 Real-world evidence to date has shown significantly lower rates of symptomatic COVID-19 and/or hospitalization/death in immunocompromised patients receiving tixagevimab and silgavimab compared to control arms. This includes real-world evidence gathered during the Omicron. BA.5, BA.4, BA.2, BA.1 and BA.1.1 they were wandering
The antibody combination received a marketing authorization in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients earlier this year and is now available in most countries in Europe, including Spain.
FISHING ROD
TACKLE a Phase III multicenter, randomized, double-blind, placebo-controlled study Evaluation of the safety and efficacy of a single 600 mg IM dose of the antibody combination (300 mg cilgavimab and 300 mg tixagevimab) compared to placebo in the treatment of mild to moderate COVID-19. The trial was conducted at 95 centers in the United States, Latin America, Europe, and Japan. 903 participants were randomized (1:1) to receive this treatment (n = 452) or saline placebo (n = 451) and administered as two separate sequential IM injections.
Participants Adults 18 years and older have mild to moderate COVID-19 and have been symptomatic for seven days or less. Participants were not vaccinated against COVID-19 at the time of screening of any respiratory tract specimens (eg, Day 1) collected up to three days prior to testing.
Detailed results of TACKLE, published Lancet Respiratory Medicine, showed that the combination of antibodies significantly reduced the relative risk of progression to severe COVID-19 or death (from any cause) by 50%. (confidence interval [IC] 95%: 15, 71; p = 0.010) Primary endpoint of the study compared to placebo at day 29 in non-hospitalized patients with mild to moderate COVID-19 who are symptomatic for seven days or less. In prespecified analyzes of participants treated within three days of symptom onset, the antibody combination reduced the risk of developing severe COVID-19 or death (from any cause) by 88% (95% CI: 9, 98) compared to placebo, and participants taking tixagevimab and silgavimab within the next five days had a risk reduction of 67% (95% CI: 31, 84) compared to placebo.
The treatment was generally well tolerated in the trial. Adverse events (AEs) occurred more frequently in the placebo group (163/451; 36%) than in the antibody combination group (132/452; 29%). The most common AEs were COVID-19 pneumonia, which occurred in 49 participants (11%) in the placebo group and 26 participants (6%) in the other group. produced Severe AEs occurred in 54 participants (12%) in the placebo group and 33 participants (7%) in the antibody combination group.. Six deaths from COVID-19 were reported in the placebo group and three in the treatment group.
Previously
Formerly known as medicine AZD7442, is a combination of two long-acting antibodies (tiksajevimab (AZD8895) and silgavimab (AZD1061)) extracted from B cells donated by convalescent patients after SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, human monoclonal antibodies bind to different sites in the spike protein of SARS-CoV-2 and have been optimized by AstraZeneca with half-life prolongation and reduction of Fc effector function and C1q complement. binding. The half-life extension increases the durability of action by more than three times compared to conventional antibodies; Data from the PROVENT Phase III study show six months of protection. The reduced Fc effector function is intended to minimize the risk of antibody-enhanced disease, a phenomenon where virus-specific antibodies promote rather than inhibit infection and/or disease.
The antibody combination is licensed for use for: prophylaxis Prior exposure (prevention) to COVID-19 in the United States (emergency use), EU, Japan and many other countries. It is also approved in Japan for the treatment of people with risk factors for severe SARS-CoV-2 infection. regulatory filings they are making progress worldwide for both preventive and therapeutic indications.