AstraZeneca COVID-19 antibody authorized by FDA as novel tool to prevent symptomatic disease

The US Food and Drug Administration has authorized a preventive antibody combination from AstraZeneca plc that has shown strong effectiveness in reducing the risk of symptomatic COVID-19, offering a first-of-its-kind option for a minority of people for whom vaccines considered less effective. ,

The antibody cocktail, called Evushield, is intended primarily for use in adolescents and adults 12 years of age and older with moderate to severely compromised immune systems. This may be because they have cancer or some other disease or take medications or undergo treatments such as chemotherapy that block the immune response to COVID-19 vaccines, the FDA said in a statement.

AstraZeneca said earlier this year that it would target the antibody combination, called AZD7442 and, like a vaccine, to be delivered as two consecutive shots to prevent COVID-19 symptoms. Emergency use authorization from the FDA provides a new preventive option in addition to widely deployed vaccines.

AstraZeneca said that nearly seven million people in the US could benefit from Evusheeld, which, if taken before exposure, could reduce the risk of symptomatic COVID-19.

Monoclonal antibodies are the only drug treatment authorized for mild to moderate COVID-19 cases in people who are not sick enough to require hospitalization. The drugs, which are given by infusion or injection, provide a temporary alternative to antibodies produced by the immune system to fight viruses after infection or vaccination.

AstraZeneca’s drug is the first drug to receive US approval to prevent COVID-19 in people who are not yet infected, but the company could face competition in the coming months. Regeneron Pharmaceuticals Inc. Including rivals are also seeking authorization for drugs to temporarily protect against infection.

Regeneron said in November that its antibody drug Regene-CoV was 82% effective at preventing infection at least eight months after infusion in a study involving patients who had not yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill, Paxlovid, to prevent infection in people who have recently been exposed to the virus, which may provide another option for people with weakened immune systems.

The FDA said the authorization is for individuals who are not infected or have not recently come into contact with someone infected with the virus. It said vaccines are “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Evushield could help reduce the risk of COVID-19 in a subset. Populations with a history of adverse reactions to COVID-19 vaccines or their components or with weakened immune systems.

“Pre-exposure prevention with Evushield is not a substitute for vaccination in individuals for whom COVID-19 vaccination has been recommended,” the FDA said.

The antibody treatment is different from AstraZeneca’s widely used COVID-19 vaccine developed in partnership with the University of Oxford. The vaccine is one of the most widely distributed globally, with more than 2.2 billion doses distributed, but it is not authorized for use in the US.

AstraZeneca said it is testing Evushield against the new Omicron version. Mayne Pangalos, the company’s executive vice president for biopharmaceuticals research and development, said in a statement, “It neutralized all previous SARS-CoV-2 variants to date, and we are looking forward to establishing its efficacy against the new Omicron variants.” Working fast.”

Some scientists think that the omicron may have evolved in a patient whose immune response was too weak to clear the virus, giving it time to adapt and mutate. The rise of variants such as Omicron highlights the need for treatments to better protect those who mount a weakened immune response to the virus, scientists say.

In August the company said that Evushield, also known as AZD7442, showed 77% efficacy in reducing the risk of symptomatic COVID-19, following late-stage clinical trials testing its usefulness as a preventive treatment. compared to a placebo. In summarizing preliminary findings, the company said that more than three-quarters of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could make vaccines less effective.

Safety has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.

Monoclonal antibody drugs are designed to mimic the natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca had previously hoped that the therapy could be used to treat acute symptoms of COVID-19 and stem infections from people already out of hospital. But the drug failed in late-stage trials for that primary purpose.

Earlier in the pandemic, AstraZeneca received a funding pledge of more than $700 million from the US government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibody used was developed by Vanderbilt University Medical Center and was licensed to AstraZeneca in June 2020.

European drug regulators are also reviewing data for possible authorization of the antibody combination.

This story has been published without modification in text from a wire agency feed