EU medicines regulator approves Regeneron virus therapy

  • 2021-02-28
  • LETA/AFP/TBT Staff

THE HAGUE - Europe's medicines regulator on Friday provisionally approved use of US biotech firm Regeneron's Covid-19 therapy, saying it prevented patients with the virus 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 preliminary results showed treatment with REGN-COV2 reduced the amount of the virus in the back of the nose and throat and led to fewer medical visits.

"The Agency concluded that... REGN-COV2 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," it said in a statement.

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

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, the EMA said.

A rolling review of the two antibodies, which started on February 1 "was ongoing", the medicines regulator said, adding "once finalized it will be the basis for an EU marketing authorization for this combination".

The US-based Food and Drug Administration in November approved emergency use of REGN-COV2, experimentally used to treat Trump.

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

The EMA however did not make an announcement Friday on the approval of Johnson & Johnson's coronavirus jab, which earlier this month applied for authorisation within the European Union.

So far, three vaccines made by Pfizer/BioNTech, Moderna and AstraZeneca have been approved by the EMA.

A US panel of independent experts were meeting Friday to discuss whether to grant J&J's covid shot the go-ahead in the United States.

Friday's announcements followed the Amsterdam-based EMA's monthly meeting, where it also recommended the approval of six other medicines including the first oral treatment for patients with certain types of spinal muscular atrophy.

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