© Reuters. FILE PHOTO: AstraZeneca logo will be seen outside its North America headquarters in Wilmington, Delaware, USA on March 22, 2021. REUTERS / Rachel Wisniewski
(Reuters) – The European Medicines Agency said Thursday it had started a real-time review of AstraZeneca's (NASDAQ 🙂 antibody-based COVID-19 therapy, the first vaccine to be used alongside vaccines against coronavirus.
The decision by the European Medicines Agency (EMA) Human Medicines Committee to start the rolling review was based on early clinical trial results, the regulator said https://www.ema.europa.eu/en/news/ema-start- rolling-review-evusheld-tixagevimab-cilgavimab. It was not stated when a graduation was expected.
The move to launch a real-time review, so-called because the data is evaluated as it is made available, came about a week after the Anglo-Swedish drug manufacturer applied for emergency approval from the US authorities.
While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AstraZeneca's biotechnological agent, which operates under the brand name Evusheld, contains laboratory-made antibodies that are supposed to stay in the body for months to contain the virus in the event of an infection .
The drug has been shown to work in uninfected people and was also able to save lives and prevent serious illness this week when given for treatment within a week of the first symptoms.
"The EMA will evaluate further data on the quality, safety and efficacy of the medicine as it becomes available," said the European Union (EU) Guardian, adding that the review will continue until AstraZeneca can submit a formal application for approval.
AstraZeneca has informed https://www.reuters.com/world/us/astrazeneca-files-us-approval-drug-prevent-covid-19-2021-10-05 that it is dealing with supply agreements for Evusheld, also known as AZD7442 , goes, run with the United States and other governments.
There are some COVID-19 therapies based on the same class of drugs as AstraZeneca, called monoclonal antibodies, that aim to treat the disease rather than prevent it. They are being sold outside the EU by rivals Regeneron (NASDAQ :), Eli Lilly (NYSE 🙂 and GSK-Vir to prevent the disease from getting worse in early, milder stages of infection.
Other antibody-based COVID-19 treatments that are being reviewed in real time by the EMA are treatment for GSK-Vir, Sotrovimab, and Lilly's Cocktail. Gilead's Remdesivir (NASDAQ 🙂 is the only drug of any kind approved in the EU https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus -Krankheit- Covid-19 / Treatments-Vaccines / Covid-19 Treatments for COVID Treatment.
The EMA is also considering an ongoing review of Merck's experimental COVID-19 pill https://www.reuters.com/business/healthcare-pharmaceuticals/ema-consider-rolling-review-mercks-molnupiravir-coming-days- 2021-10-05.
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