AstraZeneca's Long-Acting Antibody Cocktail Evusheld Receives EU Approval for Both Prevention and Treatment of COVID-19
AstraZeneca
Biopharmaceutical Manufacturer
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
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News on September 23, 2022 / BIOON / -- AstraZeneca recently announced that the European Commission (EC) has approved itsLong-acting antibody cocktail therapy Evusheld (Chinese name: 恩适得, generic name: tixagevimab + cilgavimab, trade name: 替沙格韦单抗联合西加韦单抗, formerly known as AZD7442): used to treat patients who do not require supplemental oxygen and whose condition has progressed to severe.COVID-19（COVID-19) in adult and adolescent patients (aged ≥12 years, weight ≥40 kg) at increased risk.The recommended dose of Evusheld is 150mg tixagevimab + 150mg cilgavimab, with the two antibodies administered separately by consecutive intramuscular (IM) injections.
In March 2022, Evusheld was approved in the EU:For pre-exposure prophylaxis (PrEP) against COVID-19 in a broad population of adults and adolescents (aged ≥12 years, weight ≥40 kg).There is evidence that,In high-risk populations, compared with placebo, Evusheld significantly reduced the risk of developing symptomatic COVID-19, with protective effects lasting at least 6 months.
With today's new approval,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.
The approval of Evusheld for the treatment of COVID-19 was based on the results of the TACKLE Phase 3 COVID-19 treatment trial.The TACKLE trial was conducted in non-hospitalized adult patients with mild to moderate COVID-19 whose symptoms persisted for ≤7 days. Ninety percent of the trial participants were at high risk of progressing to severe COVID-19 due to comorbidities or age.The results showed,Compared with placebo, a single intramuscular (IM) dose of Evusheld in clinical andStatisticsIt has a significant protective effect, capable of significantly reducing the risk of disease progression to severe COVID-19 or death for any reason. Administering Evusheld treatment early in the course of the disease can lead to more favorable outcomes.
The specific data is as follows:By Day 29, compared with placebo, Evusheld significantly reduced the relative risk of developing severe COVID-19 or death (from any cause) by 88%, 67%, and 50% in patients treated within 3 days, 5 days, and 7 days after symptom onset, respectively. In this trial, Evusheld was generally well tolerated.
"Many people, including those who are immunocompromised, elderly, and have underlying health conditions, are at high risk of developing severe illness, requiring hospitalization, and facing mortality if infected with the coronavirus. Evusheld, provided in a convenient intramuscular injection formulation, will now become a much-needed, new COVID-19 treatment option for these vulnerable populations," said Dr. Michel Goldman, former Executive Director of the European Innovative Medicines Initiative and Professor at the Interdisciplinary Innovation Institute for Healthcare at the Free University of Brussels.
Evusheld is a long-acting antibody cocktail therapy composed of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061), which are derived from B cells donated by convalescent patients after SARS-CoV-2 infection.These two monoclonal antibodies were discovered by the Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. Tixagevimab and cilgavimab target two different sites of the SARS-CoV-2 spike protein, respectively, and have a synergistic effect, which can reduce the risk of viral variant escape.
AstraZeneca optimized these two monoclonal antibodies, extending their half-life and reducing Fc receptor and complement C1q binding. Compared with traditional antibodies, the half-life has been extended more than threefold. The purpose of reducing Fc receptor binding is to minimize the risk of antibody-dependent enhancement (ADE) of disease, a phenomenon where virus-specific antibodies promote rather than inhibit infection and/or disease.
In March 2022, Evusheld was approved in the European Union for prophylactic indications: pre-exposure prophylaxis (PrEP) of COVID-19 for a broad population of adults and adolescents (aged ≥12 years, weighing ≥40 kg). Data from the PROVENT Phase 3 PrEP trial showed that Evusheld significantly reduced the risk of developing symptomatic COVID-19, with protection lasting at least six months. Specifically, at the time of preliminary analysis,Compared with placebo, prophylactic use of Evusheld reduced the risk of developing symptomatic COVID-19 by 77%; in the median 6-month analysis, the risk was reduced by 83%, indicating that the protective effect lasts for at least six months.In this trial, Evusheld was generally well-tolerated. (Bioon.com)
Source: Evusheld Long-Acting Antibody Combination Approved in the EU for the Treatment of COVID-19