AstraZeneca to seek approval for Covid antibody cocktail

Coronavirus treatment updates

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AstraZeneca will move to seek regulatory approval of its antibody cocktail after a study showed the drug significantly reduced the risk of developing symptomatic Covid-19.

That would make it the first long-acting drug that is not a vaccine that has demonstrated prevention of the disease in a clinical trial.

The Anglo-Swedish drugmaker said on Friday that its AZD7442 antibody combination showed a 77 per cent reduction in the development of symptomatic Covid compared with a placebo.

There were no severe Covid cases or deaths in those treated with the drug, while the placebo arm accrued three cases of severe disease, including two deaths.

More than three-quarters of the 5,197 late-stage trial participants had other underlying medical conditions, the company said, including conditions that have been reported to cause a lowered immune response to vaccination. Of these, 5,172 were not infected with coronavirus at the beginning of the study.

The drug could be suitable for patients for whom a vaccine is not recommended. It offers up to a full year of protection from Covid and is delivered by intramuscular injection.

The drug was well-tolerated, AstraZeneca said, and adverse events were “balanced” between the drug and placebo cohorts.

Mene Pangalos, the drugmaker’s chief of research and development, said “additional approaches” were needed for those that Covid vaccines could not protect. He said the company was “very encouraged” by the data released on Friday.

AstraZeneca said preliminary cell studies showed the cocktail neutralises emergent viral variants, including Delta.

While there are several safe and effective vaccines approved across the world, including one made by Oxford university and AstraZeneca, the quest to find effective treatments, especially those that work to prevent symptomatic Covid, has been less successful.

Most treatments either target viral replication directly, or the body’s immune overreaction in severe cases, but they are all approved for treatment after exposure or when infection is confirmed, and not before.

A trial for the same antibody cocktail in June had failed to show results, but it was devised to study the combination in patients who had already been exposed to the virus. AstraZeneca said then it was hopeful the drug could work to prevent disease if it was given early enough.

AstraZeneca has a deal with the US to supply up to 700,000 doses of the treatment for up to $726m.

Antibody cocktails are difficult to administer and expensive to make, making them cost-effective only if their effects are significant.

Preventive approaches in infectious disease have been shown to be game-changers, including for HIV, where existing and licensed treatments can lower the risk of contracting the infection by up to 99 per cent.

Separately, the UK regulator approved its first monoclonal antibody treatment for Covid-19 on Friday.

Ronapreve, the drug from Regeneron and Roche that former US president Donald Trump credited for his recovery from the disease, has been available in the US since November last year. 

The treatment contains two antibodies that boost a patients’ immune response and can also be used to prevent infection in high risk settings. But as an infusion, it can be tricky to deliver at the right time to have the most significant impact, and scientists are still searching for a pill to tackle the virus.

Additional reporting by Hannah Kuchler and Leke Oso Alabi