Hungary has received the first shipment of Regeneron’s experimental Covid drug used to treat former U.S. President Donald Trump after he caught the virus last October, according to news site Azonnali.
Europe’s medicines regulator (EMA) provisionally approved the use of Regeneron’s Covid-19 therapy in February; since then it has been used in several EU countries including Germany and the Czech Republic.
Hungary’s national hospital manager (OKFŐ) also received the first thousand doses of Regeneron’s monoclonal antibody cocktail on Wednesday, Azonnali reports, which means it can soon be used in hospitals as well.
The news site asked Swiss drugmaker Roche (which teamed up with Regeneron in August) about the requirements for the use of their drug in Hungary.
The company said that even though EMA’s marketing authorization procedure had not yet concluded, the agency’s recommendation allows national authorities of the EU Member States to authorize the use of the product in accordance with the local regulations even before EMA’s final approval.
This means it is Hungary’s Medicines Agency (OGYÉI) that will make the product available to Hungarian patients within the framework of a so-called “pre-authorization drug application.” According to the procedure, each hospital must submit an application to the OGYÉI, which will then issue a temporal license for the use of the drug.
The company also revealed that the procurement agreement was reached between Roche and OKFŐ in April 2021, and Hungary was among the first countries in the EU to receive the medicine, of which the first thousand doses were handed over on Wednesday.
Regeneron’s monoclonal antibody cocktail became widely known after it was administered to former U.S. President Donald Trump who contracted Covid-19 last October, which he later called a life-saver.
Officially, the synthetic antibody treatment is called REGN-COV2, while Regeneron in fact is the name of the New York-based pharmaceutical company that makes the medicine.
The drug is a combination of casirivimab and imdevimab, two monoclonal antibodies which are given to patients via infusion. Monoclonal antibodies are lab-made versions of the body’s natural infection-fighting defenses. The two antibodies have been designed to attach to the spike protein of the coronavirus at two different sites, stopping it from entering the body’s cells.
Results from a recent phase 3 clinical trial show that the antibody cocktail can reduce COVID-19 hospitalization and death by 70 percent, while also shortening the duration of symptoms by four days.
According to experts, the antibody drug is indeed effective, but only if it is used at a very early stage of the infection, while it shows less significant efficacy in later stages.
Featured photo illustration by Zoltán Balogh/MTI