The EU Medicines Agency approves Regeneron’s Covid-19 synthetic antibody therapy

Europe’s drug regulator on Friday tentatively approved the use of the American biotechnology company Regeneron’s Covid-19 therapy and said it prevented patients from getting worse.

Regeneron’s synthetic antibody treatment was used to treat former US President Donald Trump after he contracted coronavirus last year.

The European Medicines Agency said that preliminary results showed that treatment with REGN-COV2 reduced the amount of virus in the back of the nose and throat and led to fewer medical visits.

“The agency concluded that … RAIN-COV2 can be used to treat confirmed Covid-19 in patients who do not need extra oxygen and who are at high risk of developing severe Covid-19,” the statement said.

RAIN-COV2 is a combination of casirivimab and imdevimab, two monoclonal antibodies given to a patient via drip, the EMA said.

Monoclonal antibodies are laboratory-made versions of the body’s natural anti-infective defenses.

The two antibodies have been designed to attach to the coronavirus’ nail protein in two different places, preventing it from entering the body’s cells, the EMA said.

A rolling review of the two antibodies, which started on February 1, “was ongoing”, the Pharmaceutical Agency said, adding “when completed, it will form the basis of an EU marketing authorization for this combination”.

In November, the US-based Food and Drug Administration approved the emergency use of REGN-COV2, which was used experimentally to treat Trump.

On Thursday, France also announced that it had distributed thousands of monoclonal antibody treatments to hospitals, with Health Minister Olivier Veran saying “there are new hopes … that strengthen our anti-Covid arsenal”.

However, the EMA did not announce on Friday the approval of Johnson & Johnson’s coronavirus jab, which earlier this month applied for a permit in the European Union.

To date, three vaccines manufactured by Pfizer / BioNTech, Moderna and AstraZeneca have been approved by EMA.

A US panel of independent experts met on Friday to discuss whether J & J’s covid would send a clear signal in the US.

Friday’s announcements followed the Amsterdam-based EMA’s monthly meeting, which also recommended the approval of six other drugs, including the first oral treatment for patients with certain types of spinal atrophy.

This rare and often fatal genetic disease causes muscle weakness and progressive loss of movement.