EU authorises 2 medicines for people at risk of severe COVID

AMSTERDAM: The European Medicines Agency has recommended the authorisation of two new medicines against the coronavirus for people at risk of severe disease.

In a statement on Thursday, the EU drug regulator said it had concluded that the monoclonal antibody treatments — a combination of casirivimab and imdevimab, and the drug regdanvimab — have both been proven to significantly reduce the risk of hospitalisation and death in patients vulnerable to serious COVID-19.

The EMA described the safety profile of both medicines as “favourable," and said that despite a small number of side effects, “the medicines' benefits are greater than their risks.”

The drug combination of casirivimab and imdevimab is made by Roche; it was granted an emergency use license by the U.S. Food and Drug Administration last November.

The EMA said both regdanvimab and the casirivimab and imdevimab combination should be offered to people over age 12 who don't yet require oxygen support, but are at risk of worsening COVID-19.

It said the combination drug can also be used preventatively.

Both drugs must be administered intravenously.

Regdanvimab is made by Celltrion Healthcare in Hungary and has been previously authorized by South Korea.

Antibody treatments remain one of a handful of therapies that can blunt the worst effects of COVID-19, and they are the only option available to people with mild-to-moderate cases who aren't yet in the hospital.

The drugs are laboratory-made versions of virus-blocking antibodies that help fight off infections.

The treatments help the patient by supplying concentrated doses of one or two antibodies.