EMA begins real-time review of AstraZeneca’s COVID antibody cocktail

pharmafile | October 15, 2021 | News story | Medical Communications  

The human medicines committee of the EMA has begun the rolling review of AstraZeneca’s antibody-based COVID-19 therapy, the first protective shot other than vaccines against coronavirus.

The decision was based on early results from clinical studies, and comes roughly a week after the Anglo-Swedish drug maker sought emergency approval from US authorities.

While current vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AstraZeneca’s biotech compound, to be branded as Evusheld, contains lab-made antibodies designed to linger in the body for months containing the virus, in case of an infection.

The therapy has been proven to work among people who are not infected and was also shown this week to save lives and prevent severe disease when given as treatment within a week of first symptoms.

Read: AstraZeneca’s antibody cocktail cuts risk of severe COVID in half, study finds

AstraZeneca has said that talks regarding supply agreements for Evusheld, also known as AZD7442, are ongoing with the United States and other governments.

Other therapies based on the same class of medicine as AstraZeneca, monoclonal antibodies, are currently being sold by Regeneron, Eli Lilly, and GSK-Vir. These are also aiming to stop the disease from worsening during early, milder stages of the infection.

Other antibody-based COVID-19 treatments under a real-time review by the EMA are GSK-Vir’s treatment, Sotrovimab, and Lilly’s cocktail.

Currently Gilead’s remdesivir is the only drug of any kind to be approved in the EU as a COVID treatment.

The EMA is also considering a rolling review of Merck’s experimental COVID-19 pill, its head of vaccine strategy said earlier this month, after interim data showed the treatment could halve the chances of dying or being hospitalised for those most at risk.

Marco Cavaleri, the EMA’s head of vaccine strategy, told reporters: “We will be considering whether to start a rolling review for this compound in the next days. And of course, the idea is to understand if the data supports such (a) rolling review”.

Kat Jenkins

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