AZ files for emergency use of COVID-19 antibody combo in US
AstraZeneca has sought emergency use authorisation for its antibody combination AZD7442, following trial results indicating it can prevent symptomatic COVID-19 infection when given to healthy patients.
AZD7442 (tixagevimab/cilgavimab) is the first long-acting antibody drug that has demonstrated it can be used in this way, reducing the risk of symptomatic COVID-19 by 77% compared to placebo in the recently reported PROVENT trial.
AZ hopes that approval could make the drug the first non-vaccine option for COVID-19 prevention, which could be used to protect vulnerable people, such as those with weakened immune systems who may not mount an effective immune response after immunisation.
PROVENT studied a single dose of AZD7442 given by intramuscular injection compared to placebo in 5,200 patients, following patients for six months after dosing, although AZ thinks it may confer protection for up to 12 months.
There were 25 cases of COVID-19 overall in the study, with no cases of severe COVID-19 or coronavirus-related deaths in subjects treated with AZD7442. In contrast, there were three cases of severe COVID-19, which included two deaths.
“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” said Mene Pangalos, AZ’s head of biopharmaceutical R&D.
The company is also submitting preliminary data from the ongoing STORM CHASER trial, which is testing whether a dose of the antibody can prevent COVID-19 in people who have been in contact with someone with a confirmed SARS-CoV-2 infection. Initial results from that study were negative.
At the same, time, AZ is also evaluating use of the antibody to treat people who already have COVID-19, and results from that study are due before the end of the year.
The EUA fling puts AZ in the lead among COVID-19 antibody developers for prevention, although it is playing catch-up with other companies when it comes to using the drug to treat infection.
The FDA has issued EUAs for three antibody-based drugs as therapies for COVID-19, namely GlaxoSmithKline/Vir Biotechnology’s sotrovimab, Eli Lilly’s bamlanivimab/etesevimab, and Regeneron’s casirivimab/imdevimab.
AZ said that discussions are ongoing with the US and other governments that may lead to supply agreements.
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