The EMA (EUROPEAN MEDICINES AGENCY) said on Friday that the Regeneron Pharmaceuticals’ antibody cocktail for COVID-19, also known as REGN-COV2 antibody combination (casirivimab / imdevimab), can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
The medicine is given by infusion (drip) into a vein and the proposed conditions of use are available.
EMA made its recommendations following review of data including quality data and a study that looked into the effects of the combination in outpatients with COVID-19 who do not need supplemental oxygen.
Preliminary results indicate that the combination reduced the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment) and led to fewer COVID-19-related medical visits.
In terms of safety, most side effects reported were mild or moderate, however reactions related to the infusion (including allergic reactions) have been seen and should be monitored for, EMA said.
The recommendation can now be used as guidance in individual European nations on the possible use of the combination of casirivimab and imdevimab before a marketing authorisation is issued, the European Medicines Agency (EMA) said.
In parallel, a rolling review of the combination of antibodies casirivimab and imdevimab, which started on 1st February, is currently ongoing.
Once finalised it will be the basis for an EU marketing authorisation for this combination.
The treatment is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections.
Regeneron’s antibody cocktail was authorised for emergency use in the United States in November, and was given to former U.S. President Donald Trump during his COVID-19 infection.
This medicine is made of casirivimab and imdevimab, two monoclonal antibodies.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites.
When the active substances are attached to the spike protein, the virus is unable to enter the body’s cells.
For more information
EMA (EUROPEAN MEDICINES AGENCY)
The NEW ENGLAND JOURNAL of MEDICINE
REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19
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