AstraZeneca announces drug Evusheld to prevent COVID-19 or death
Date 18 June 2022 time 05:45
AstraZeneca Trials Phase III TACKLE Drug Evusheld Could Prevent COVID-19 Progression or death
The study, published in the journal The Lancet Respiratory Medicine, demonstrates the usefulness of Evusheld in the treatment of COVID-19. for outpatients with mild to moderate symptoms
Results of the TACKLE trial, a phase III study in the treatment of COVID-19. in the outpatient group It was shown that AstraZeneca’s Evusheld (formerly AZD7442, a combination of two long-acting antibodies, tixagevimab and cilgavimab), was able to prevent the development of severe disease. or death from all causes were clinically and statistically significant Compared to the placebo group treated with Evusheld in the early stages of disease, can lead to better results1
The data is published in the journal The Lancet Respiratory Medicine. The Tackle trial studied co-inpatient outpatients with COVID-19. with mild to moderate symptoms lasting no more than 7 days. In addition, 90% of participants had underlying diseases and conditions at risk of severe infection with COVID-19. or an elderly person1
Hugh Montgomory, Professor at the Department of Intensive Medicine University College London and lead researcher for Project Tackle will have broad success But there are still many populations who are still at high risk of developing severe disease, such as the elderly, those with congenital diseases. and those with impaired immune systems so other methods Therefore it is necessary to prevent disease progression. and reduce the burden on the public health system especially with the emergence of various new species. continually Tackle trial shows that intramuscular injection of one dose of Evusheld can prevent the progression of COVID-19. to a severe stage The faster the drug is received, the more beneficial the treatment will be.”
Sir Mene Pangalos, Executive Vice President of Research and Development for Biopharmaceuticals AstraZeneca’s Biopharmaceuticals said: “The findings published in The Lancet Respiratory Medicine further support the use of Evusheld to help patients in need of COVID-19 prevention. more than ordinary people Currently, the data from this study are being discussed with relevant agencies. And there are ongoing applications for drug registration in both therapeutic and preventive indications. to fight against COVID-19 in every aspect.”
The primary endpoint of the Tackle trial showed that one 600 mg dose of Evusheld for intramuscular injection reduced the risk of developing severe disease. or death Patients (all causes) were up to 50% (95% confidence interval (CI) 15, 71; p=0.010) after 29 days of drug exposure compared to the placebo group. Outpatients with mild to moderate symptoms and have symptoms for a period of not more than 7 days
from the analysis of pre-specified In COVID-19 patients who show symptoms and receive medication within the first three days, Evusheld can reduce the risk of developing severe disease. or died The risk reduction (all causes) was 88% compared to the placebo group (95% confidence interval (CI) 9, 98), and the risk was reduced by 67% (95% confidence interval). (CI) 31, 84) in the drug group within 5 days of symptom onset.1
Additionally, in the secondary endpoint reported, Evusheld was able to reduce the risk of respiratory failure by 72% (95% confidence interval (CI) 0.3, 92; nominal p=0 036) with Three (0.7%) Evusheld recipients compared to 11 (3%) placebo recipients who required other instrumental therapy such as mechanical ventilation. or a portable artificial heart-lung machine (ECMO)1.
According to studies, the Evusheld technique has well-tolerated side effects. More adverse events (AEs) were reported in the placebo group than with Evusheld (36% and 29%, respectively). The most common adverse event was pneumonia in patients with COVID-19. This occurred in 49 (11%) placebo-treated groups and 26 (6%) in the Evusheld group. Severe adverse events occurred in 12% in the placebo-treated group and in 7% in the Evusheld1 group, with 6 deaths reported in the placebo group and 3 in the Evusheld1 group.
TACKLE TRIAL (TACKLE)
The TACKLE Trial (TACKLE) was a randomized, phase III trial with both masking and veiled data. and placebo-controlled studies in multiple trial centers. To know the safety and efficacy of Evusheld 1 dose 600 mg intramuscular injection. Compared with placebo in the treatment of outpatients with COVID-19. with mild to moderate symptoms The trials were conducted at 95 centers in the United States, Latin America, Europe and Japan. A total of 903 participants were randomized to receive either Evusheld or saline in a 1:1 ratio. There were 452 Evusheld subjects and saline. A total of 451 subjects were placebo, two consecutive intramuscular injections.
Participants in the program are patients infected with COVID-19. 18 years of age and older with mild to moderate symptoms and showing symptoms in a period of not more than 7 days, a type that does not require hospitalization Participants are required to receive documents confirming SARS-CoV-2 infection by molecular testing. (antigen or nucleic acid assay) from taking samples from the respiratory system (eg oral, nasopharynx, or mucus or saliva), which are collected no more than 3 days before the date of participation in the program. Participants must not have been vaccinated against COVID-19 at the time of screening.
Primary efficacy consisted of having symptoms of severe COVID-19 infection or all-cause death during 29 days, with participants being followed up for 15 months.
About 13% of participants were aged 65 and over. In addition, 90% of participants had underlying diseases and conditions at high risk of developing severe symptoms of COVID-19, including cancer. , diabetes, obesity, chronic lung disease or asthma, cardiovascular disease or immunodeficiency About 62% of the participants were Caucasian/Caucasoid, 4% were African American, 6% were Asian, 24% were Native American, and 52% were Latino.
AstraZeneca has previously announced good preliminary results from the TACKLE, phase 3 study to treat COVID-19 patients. with mild to moderate symptoms
Evusheld pills
Evusheld, formerly AZD7442, is a long-acting antibody (LAAB) that combines two LAAB drugs, tixagevimab (AZD8895) and cilgavimab (AZD1061), derived from donated B cells from previously ill patients with the virus. SARS-CoV-2, which was discovered by Vanderbute University Medical Center. AstraZeneca was authorized for further development in June 2020. The two human monoclonal antibodies will have different specificities. to bind to the thorn protein of the COVID-19 virus, or SARS-CoV-27, at two different points and was developed by AstraZeneca. to extend the half-life to increase the longevity of antibodies and adjusted for decreased Fc Receptor and C1q Complement binding3 10 By extending the half-life, the antibody longevity was more than threefold compared to that of conventional 4-6 antibodies. The data from the phase 3 experiments showed that the level of antibodies capable of suppressing the proliferation of the virus. Neutralizing antibody persists for a period of at least 6 months7, and modulation of reduced Fc receptor binding can reduce the risk of neutropenia. antibody-dependent enhancement (ADE), a phenomenon in which viral antibodies stimulate rather than inhibit infection8
There is evidence of in vitro research and in vivo experiments. (Animal) demonstrated that Evusheld can prevent infection from subspecies of Omicron. and all the worried strains that have been tested so far 9-13 from the study of the Faculty of Medicine Washington University It also confirmed the efficacy of Evusheld in neutralizing the effects of BA.2 subspecies, currently the 9-14 strain worldwide. The results also showed that Evusheld reduced viral load and was effective in preventing lung infections against all subspecies of the omicron coronavirus BA.1, BA.1.1 and BA.29. A new preclinical study from the University of Oxford found that Evusheld neutralized the activity of the omicron strains BA.4 and BA.513.
Evusheld is a registered drug formulation in the European Union. and is registered for conditional sale by the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK. For prophylaxis before exposure to the COVID-19 virus, Evusheld is registered for use as an emergency for the prevention of exposure to the COVID-19 virus. in the United States and is still allowed to be used. and sold in many countries around the world The company is currently filing Evusheld drug registrations to several countries for approval for both preventive and protective uses. and treatment of COVID-19
Evusheld is being developed with support from the United States government. including funding from US health and human services. It is supervised by the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority in collaboration with the Ministry of Defense and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under contract number W911QY-21-9-0001
Under an agreement with Vanderbutt AstraZeneca will pay a share of the royalties from future sales.
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