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Coronavirus: FDA authorises Regeneron treatment

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The U.S. Food and Drug Agency (FDA) on Saturday granted emergency autorisation for an antibody treatment against the novel Coronavirus (COVID-19) developed by the Regeneron firm and used on Donald Trump after he was diagnosed with the virus.

The FDA took the decision following evidence that REGEN-COV2, a combination of two laboratory-manufactured antibodies, reduced Coronavirus-related hospitalisations and the need for patients with underlying conditions to be rushed to emergency services.

“Authorising these monoclonal antibody therapies may help patients avoid hospitalisation and alleviate the burden on our health care system,” FDA Commissioner Stephen Hahn said in a statement.

Regeneron’s president and CEO, Leonard Schleifer, said the decision was “an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection.”

U.S. President Donald Trump had received the cocktail of monoclonal antibodies developed by Regeneron in early October and had sung its praises after his recovery.

Imitating the immune system’s ability to fight viruses, these antibodies act against COVID-19’s spike protein, blocking it from attaching itself to human cells and entering them.

It is considered more effective in the initial stage of infection, when antibodies still have a chance of overcoming the invader, but not in the second stage of COVID-19, when the danger comes not from the virus itself but from overreaction by the immune system, which then attacks the lungs and other organs.

The Brussels Times