Vaccines are the best way to stop Covid-19, but they are not an option for people with weakened immune systems or intolerance to the components of these vaccines. FDA has granted Emergency authorization A long-acting AstraZeneca drug can provide protection for these patients.
AstraZeneca (AstraZeneca) drug is an antibody therapy, it has joined a growing list of antibody drugs, these antibody drugs have passed the FDA’s emergency use ban. But this drug called Evusheld does mark a new precedent for antibody therapy: it is the first authorized method to prevent disease before an individual is exposed to the virus. Other authorizations that include antibody drugs to prevent Covid-19 may only be used to treat people who have been exposed to the virus.
Evusheld’s authorization covers the use of the drug by adults and children 12 years and older weighing at least 40 kg (approximately 88 pounds). The immune system of these people must be weakened due to physical conditions or immunosuppressive drugs. Patients with a history of adverse reactions to the components of the Covid-19 vaccine can also use the drug.
AstraZeneca tested its drug in a placebo-controlled Phase 3 study that enrolled nearly 5,200 adults age 59 and older. The health of the participants in these trials may make them poorly responding to the vaccine or otherwise intolerant to the vaccine. In addition, the trial participants had no previous history of SARS-CoV-2 infection and did not test positive for the infection at the beginning of the study.
The main goal of the key study is to see if participants have contracted Covid-19 after receiving the study drug or placebo. In August, A major analysis reported by AstraZeneca showed that people who received Evusheld had a 77% lower risk of Covid-19 compared to people who received a placebo.
Evusheld is a combination of two monoclonal antibodies, tixagevimab and cilgavimab. These antibodies were derived from the B cells of patients who recovered from SARS-CoV-2 infection and were discovered by scientists at Vanderbilt University.AstraZeneca Licensed Their rights last year. Evusheld is administered as two separate intramuscular injections, one after the other. Like other Covid-19 antibody drugs, Evusheld is designed to target the spike protein of SARS-CoV-2, preventing its ability to attach and enter human cells. In addition, as with other antibody combination therapies, the two antibodies containing Evusheld bind to different sites of the spike protein, reducing the chance of mutations that make the virus resistant to treatment.
A key difference of Evusheld may be its durability. AstraZeneca applied its proprietary technology to two Vanderbilt antibodies, extending their half-life, allowing them to last up to a year. In the results of clinical trials to date, the risk of Covid-19 in the Evusheld group was reduced by 77% for six months. AstraZeneca said that additional follow-up is needed to assess how long the benefits of the drug will last.
List FDA-authorized antibody treatments include Eli Lilly’s drugs, Regeneron Pharmaceuticals, and Partners Vir Biotechnology and GlaxoSmithKlineThe antibody combination drug of Lilly and Regeneron has been approved to treat mild to moderate Covid-19 cases and prevent disease in patients who have been exposed to the virus. The prophylactic use of the two antibody drugs covers those who are not fully vaccinated or whose immune systems are weaker than those who are unlikely to have an adequate response.Last week, the FDA expands emergency use of Eli Lilly’s antibody portfolio to children under 12 years of age, Including infants, making it the first authorized Covid-19 therapy for this young group.
AstraZeneca is still testing to evaluate how the new omicron variant affects Evusheld.company Said So far, in animal experiments, no virus changes are related to the virus’s ability to escape Evusheld’s neutralization. In laboratory tests, AstraZeneca stated that its drug can neutralize other variants, including delta and mu variants.
Evusheld is under development with the support of the US government. AstraZeneca has agreed to provide 700,000 doses of the drug to the government for distribution to all states and territories in the United States. The company said it expects the first dose of its new Covid-19 drug to be available “soon”.
Photo by AstraZeneca
