AMSTERDAM The European Medicines Agency said it has begun an expedited approval process for a combination COVID-19 drug that was granted an emergency use authorization in the U.S. in November.
In a statement on Monday, the EU regulator said it has started a “rolling review” of the drug known as REGN-COV2, developed by Regeneron Pharmaceuticals and Roche. It is made of casirivimab and imdevimab, two monoclonal antibodies.
The Amsterdam-based EMA said its decision was based on preliminary results from a study that suggests the drug could reduce the amount of virus in the blood, but said “it is too early to draw any conclusions.” It said it was evaluating the first batch of data on the drug, from laboratory and animal studies and that further data from clinical trials would be assessed as they become available.
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