AstraZeneca seeks approval for Covid antibody cocktail


Covid-19 vaccine update

After a study showed that the drug significantly reduced the risk of symptomatic Covid-19, AstraZeneca will begin seeking regulatory approval for its antibody cocktail.

This will make it the first non-vaccine long-acting drug to be proven in clinical trials to prevent this disease.

The Anglo-Swiss drugmaker said on Friday that its AZD7442 antibody combination showed a 77% reduction in the development of symptomatic Covid compared to a placebo. Among patients treated with the drug, there were no serious Covid cases or deaths, while in the placebo group there were 3 serious illnesses, including 2 deaths.

The company said that of the 5,197 late-stage trial participants, more than three-quarters had comorbidities, including conditions reported to cause a reduced immune response to vaccination. Of these, 5,172 were not infected with the coronavirus at baseline.

The drug may be more suitable for patients who are not recommended for vaccination. This drug cocktail provides Covid protection for up to a full year and is administered by intramuscular injection. AstraZeneca said the drug was well tolerated and the adverse events between the two trials were “balanced.”

Mene Pangalos, the head of research and development at the drugmaker, said that for those who cannot be protected by the Covid vaccine, “other methods” are needed. He said the company was “very encouraged” by the data released on Friday.

AstraZeneca said that preliminary cell studies have shown that this cocktail can neutralize emerging virus variants, including Delta.

Although many safe and effective vaccines have been approved around the world, including one manufactured by Oxford University and AstraZeneca, efforts to find effective treatments, especially those that can prevent symptomatic Covid, have not been successful. Most treatments either directly target virus replication or the body’s immune overreaction in severe cases, but they are approved for treatment after exposure or confirmation of infection, not before.

The June trial of the same antibody cocktail failed to meet its primary endpoint, but the trial was designed to study a combination of patients who have been exposed to the virus. AstraZeneca said at the time that if the drug is given as soon as possible, it is expected to play a role in disease prevention.

AstraZeneca reached an agreement with the United States to provide up to 700,000 doses of therapeutic drugs at a price of up to 726 million US dollars.

Antibody cocktails are difficult to manage and expensive to make, so they are only cost-effective when they are effective.

Prevention of infectious diseases has been proven to be a game changer, including HIV, and existing and licensed treatments can reduce the risk of infection by as much as 99%.

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