The European Organization said in a statement: “The decision to start this ongoing review is based on the preliminary results of an ongoing study examining the drug’s ability to prevent hospitalization or death in out-of-hospital patients with Covid-19.”
Continuous review is a regulatory procedure that the EMA uses to speed up the evaluation of a promising drug during a public health emergency, such as the current pandemic, after it has already been used in the various vaccines against covid-19 that are being used. European Union (EU).
According to the body responsible for scientific evaluation, supervision and drug safety in the European Union, the agency’s experts have not yet received the complete drug data set developed by the pharmaceutical companies GlaxoSmithKline and Vir Biotechnology, and it is still too early to draw any conclusions about the risk-benefit ratio.
“EMA has already started evaluating the first batch of data, from laboratory and animal studies, as well as data on drug quality. He said the EMA will evaluate all data, including evidence from clinical trials, as soon as it becomes available. “
According to an Amsterdam-based agency, it is not yet possible to predict a general schedule for a continuous review to assess the efficacy, safety, and quality of sotrovimab, but this process should be “faster than regular evaluation” of the drug.
On April 15, the European regulator announced that it was analyzing data regarding the use of this monoclonal antibody, also known as VIR-7831, to support countries in making a decision on the use of this drug.
At this point, the EMA said: “The EMA is initiating this review to support national authorities who can make a decision on the use of this drug for covid-19 prior to obtaining marketing authorization.”
This drug is designed to bind to the SARS-CoV-2 “spike” protein, which causes Covid-19 disease, which limits the ability of this virus to enter the cells of the body, and EMA experts hope that in this way it will reduce the need for hospitalization in people with the new Coronavirus. .
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