AstraZeneca Covid-19 antibody cleared by the FDA as a new tool to prevent symptomatic disease


The United States Food and Drug Administration has cleared a combination of preventive antibodies to AstraZeneca AZN 0.68%

PLC which has shown strong efficacy in reducing the risk of symptomatic Covid-19, offering a unique alternative for a minority of people for whom vaccines are considered less effective.

The antibody cocktail, called Evusheld, is primarily intended for use in a minority of adolescents and adults 12 years of age and older with moderate to severely compromised immune systems. This may be because they have cancer or another disease or are taking drugs or undergoing treatments such as chemotherapy that suppress an immune response to Covid-19 vaccines, the FDA said in a statement. .

AstraZeneca said earlier this year it would target the combination of antibodies, called AZD7442 and given as two consecutive injections, to prevent symptoms of Covid-19, like a vaccine. The FDA’s emergency use clearance offers a new preventative option in addition to widely deployed vaccines.

AstraZeneca said about seven million people in the United States could benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.

Monoclonal antibodies are the only drug treatments allowed for mild to moderate cases of Covid-19 in people who are not sick enough to be hospitalized. The drugs, which are given by infusion or injection, temporarily replace the antibodies produced by the immune system to fight the virus after infection or vaccination.

AstraZeneca’s drug is the first to gain US clearance to prevent Covid-19 in people who are not yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc.

also seek authorization of drugs to temporarily defend against infection.

Regeneron said in November that its antibody drug REGEN-COV was 82% effective in preventing infection at least eight months after the infusion in a study that included patients who had not yet been exposed to the virus. Pfizer Inc.

is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which may offer another option for people with weakened immune systems.

The FDA said the clearance is for people who are uninfected or have been recently exposed to someone infected with the virus. He said vaccines remain “the best available defense against Covid-19”. In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with a weakened immune system.

“Pre-exposure prevention with Evusheld is not a substitute for vaccination in people for whom vaccination against Covid-19 is recommended,” the FDA said.

The antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. This vaccine is one of the most widely distributed in the world, with more than 2.2 billion doses delivered, but its use is not authorized in the United States.

AstraZeneca has said it is testing Evusheld against the new Omicron variant. It “neutralizes all previous variants of SARS-CoV-2 to date, and we are working quickly to establish its effectiveness against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for research and development. biopharmaceuticals, in a press release.

Some scientists believe Omicron may have developed in a patient whose immune response was too weak to clear the virus, giving him time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who develop weak immune responses to the virus causing Covid-19, scientists say.

The company said in August that Evusheld, also known as AZD7442, had shown 77% effectiveness in reducing the risk of symptomatic Covid-19 compared to placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In a summary of preliminary results, the company said more than three-quarters of the 5,197 trial participants had co-morbidities or chronic illnesses, including conditions that could make vaccines less effective.

Protection has been shown to last for six months, the FDA and AstraZeneca said. The evaluation of the antibody combination is ongoing.

Monoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca was hoping earlier that the therapy could be used to treat the acute symptoms of Covid-19 and the rod infection to keep people already exposed to the virus out of hospital. But the drug has failed in late stage trials for this primary purpose.

Earlier in the pandemic, AstraZeneca received funding pledges of up to $ 700 million from the US government to develop, test and potentially deliver up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.

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

Write to Jenny Strasburg at [email protected] and Joseph Walker at [email protected]

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