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AstraZeneca Evusheld as COVID drug is authorized in UK
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AstraZeneca Evusheld as COVID drug is authorized in UK: for use in high-risk groups for pre-exposure prophylactic treatment of COVID-19!
AstraZeneca has announced that Evusheld (tixagevimab and cilgavimab, R&D code: AZD7442) has been authorized by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the pre-exposure prophylactic treatment of COVID-19.
There is evidence of efficacy and protection (estimated to last at least 6 months) following a single dose of Evusheld in high-risk populations.
Evusheld is for use in a population of adults who are not currently infected with (or exposed to) novel coronavirus (SARS-CoV-2) or who are unlikely to respond appropriately to COVID-19 vaccination, including adults for whom vaccination is not recommended.
The recommended dose of Evusheld is 300mg: 150mg tixagevimab and 150mg cilgavimab, the 2 antibodies are administered separately, sequentially intramuscularly. Higher doses of 600 mg (300 mg tixagevimab, 300 mg cilgavimab), may be more appropriate for some SARS-CoV-2 variants (eg, Omicron BA.1, Omicron BA.1.1).
The use of Evusheld should be in accordance with the official recommendations of the UK Department of Health and Social Care.
Evusheld is a long-acting antibody cocktail therapy consisting of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061), which are derived from B cells donated by patients recovering from SARS-CoV-2 infection.
The two mAbs were discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. Tixagevimab and cilgavimab target 2 different sites on the spike protein of SARS-CoV-2, respectively, and have a synergistic effect to reduce the risk of viral mutation escape.
AstraZeneca optimized these two mAbs to extend the half-life, reduce Fc receptor and complement C1q binding, and increase the half-life by more than 3 times compared with traditional antibodies.
The goal of reducing Fc receptor binding is to minimize the risk of antibody-dependent enhancement (ADE) of disease, a phenomenon in which virus-specific antibodies promote rather than inhibit infection and/or disease.
Tom Keith Roach, president of AstraZeneca UK, said: “Evusheld will fill an urgent gap in the UK’s fight against COVID-19, providing protection for those at risk of ineffective vaccination, who are often the most clinically vulnerable in the community. We hope to join other countries in making this critical medicine available to UK patients as soon as possible.”
About half a million people in the UK are immunocompromised and these people may benefit from the drug for COVID-19 pre-exposure prophylaxis.
Nearly 40% of immunocompromised or immunosuppressed patients developed a low or undetectable immune response after vaccination, and about 11% were unable to develop any antibodies.
This includes patients with blood cancers, patients taking immunosuppressive drugs after organ transplants , or patients with multiple sclerosis and rheumatoid arthritis .
Data from the ongoing PROVENT Phase 3 trial, which met its primary endpoint, showed that AZD7442 prophylactic treatment significantly reduced the risk of developing symptomatic COVID-19 compared with placebo.
The trial showed that the protective effect of AZD7442 against viral infection lasted for at least 6 months. In the trial, AZD7442 was tolerated and follow-up was required to determine the full duration of protection.
Based on a preliminary analysis of 5172 participants (AZD7442 group N = 3441; saline placebo group, N = 1731): median follow-up of 83 days post-dose , comparable to placebo in terms of symptomatic COVID-19 incidence AZD7442 had a relative risk reduction (RRR) of 77% (95% CI: 46-90; p < 0.001; 8/3441 [0.2%] in the AZD7442 arm vs 17/1731 [1.0%] in the placebo arm), absolute risk The reduction (ARR) was 0.8%.
In a follow-up analysis: median follow-up of 6.5 months post-dose, AZD7442 showed an RRR of 83% (95% CI: 66-91; 11/3441 [0.3%] in AZD7442 vs placebo 31) compared to placebo /1731[1.8%]), AAR of 1.5%.
There were no hospitalizations or deaths in the AZD7442 treatment group.
In the placebo group, there were 5 severe COVID-19 and 2 COVID-19-related deaths. Adverse events were reported by 35% (1221/3461) and 34% (593/1736) of subjects receiving AZD7442 and placebo, the vast majority of which were mild to moderate.
The most common adverse reactions in the pooled analysis were injection site reactions.
*Available data suggest that tixagevimab and cilgavimab may be effective for pre-exposure prophylaxis within 6 months, based on the variability prevalent during the study period.
The trial is ongoing and more data is being generated to determine the exact duration of preventive protection.
It is not clear how pseudovirus or true SARS-CoV-2 neutralization susceptibility data correlate with clinical outcomes, but data from multiple independent studies (both pseudovirus and true “live” virus) show that antibody combinations retain resistance to Omicron neutralizing activity.
AstraZeneca’s antibody combination, Evusheld▼ (tixagevimab co-packaged with cilgavimab) authorised for use in Great Britain for pre-exposure prophylaxis (prevention) of COVID-19
AstraZeneca Evusheld as COVID drug is authorized in UK
(source:internet, reference only)