AstraZeneca Evusheld long-acting antibody combination approved in EU for the treatment of COVID-19
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AstraZeneca Evusheld long-acting antibody combination approved in EU for the treatment of COVID-19
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AstraZeneca Evusheld long-acting antibody combination approved in EU for the treatment of COVID-19.
“Prevention + Treatment” COVID-19 Pneumonia! Evusheld, a long-acting antibody cocktail, was approved for a new indication in the EU.
AstraZeneca recently announced that the European Commission (EC) has approved its long-acting antibody cocktail therapy Evusheld (generic name: tixagevimab + cilgavimab, tesagvirumab combined with sigavirumab , formerly AZD7442): for the treatment of adult and adolescent (age ≥12 years, weight ≥40 kg) patients who do not require supplemental oxygen and are at increased risk for progression to severe COVID-19 pneumonia ( COVID-19 ).
Evusheld’s recommended dose is 150mg tesagvirumab + 150mg sigavirumab, the two antibodies are administered separately, continuous intramuscular injection (IM).
In March 2022, Evusheld was approved in the European Union for pre-exposure prophylaxis (PrEP) for a wide range of adults and adolescents (age ≥ 12 years, weight ≥ 40 kg).
There is evidence that Evusheld significantly reduces the risk of developing symptomatic COVID-19 compared with placebo in high-risk populations, with protection lasting at least 6 months.
With this new approval today, Evusheld is now the only long-acting antibody combination product in Europe that can be used for both prevention (pre-exposure prophylaxis, PrEP) and treatment of COVID-19, and will be able to protect more people from this devastating disease Impact.
The approval of Evusheld for the treatment of COVID-19 is based on the results of the TACKLE Phase 3 COVID-19 treatment trial.
The TACKLE trial was conducted in nonhospitalized adult patients with mild to moderate COVID-19 with symptoms lasting ≤7 days, and 90% of trial participants were at high risk of developing severe COVID-19 due to comorbidities or age.
Results showed that a single intramuscular (IM) dose of Evusheld was clinically and statistically significant protective compared to placebo, and was able to significantly reduce the risk of developing severe COVID-19 or death from any cause.
More favorable results can be obtained by administering Evusheld treatment earlier in the course of the disease.
The specific data are: Evusheld’s relative rate of progression to severe COVID-19 or death (any cause) compared to placebo in patients treated within 3, 5, and 7 days of symptom onset through Day 29 Risks were significantly reduced by 88%, 67%, and 50%, respectively. In this trial, Evusheld was generally well tolerated.
“Many people, including the immunocompromised, the elderly and those with underlying medical conditions, There is a high risk of serious illness, hospitalization and death if contracted with COVID-19. Evusheld, delivered in a convenient intramuscular formulation, will now be a much-needed new COVID-19 treatment option for these vulnerable populations.”
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 has 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.
In March 2022, Evusheld was approved in the EU for prophylaxis indications: pre-exposure prophylaxis (PrEP) for a wide range of adults and adolescents (age ≥ 12 years, weight ≥ 40 kg).
Data from the PROVENT Phase 3 PrEP trial showed that Evusheld was able to significantly reduce the risk of developing symptomatic COVID-19, with protection lasting at least 6 months.
Specifically: Evusheld prophylaxis reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo at the time of the primary analysis; at the median 6-month analysis, the risk was reduced by 83%, indicating The protective effect lasts for at least 6 months . In this trial, Evusheld was generally well tolerated.
Original source:
AstraZeneca Evusheld long-acting antibody combination approved in EU for the treatment of COVID-19
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