Pharmaceutical Business review

WHO adds Regeneron antibody drug cocktail to Covid-19 treatment list

REGEN-COV has been recommended for use in patients at high risk of hospitalisation with Covid-19 and those severely ill with no existing antibodies. Credit: Hakan Nural on Unsplash.

The World Health Organization (WHO) has added Regeneron Pharmaceuticals and Roche’s Covid-19 antibody drug cocktail to the list of treatments for Covid-19 patients.

The agency has recommended the use of the antibody cocktail, named REGEN-COV, for non-severe Covid-19 patients at high risk of hospitalisation and those severely ill with no existing antibodies.

Designed to block SARS-CoV-2 infectivity, REGEN-COV is a combination of two monoclonal antibodies, casirivimab and imdevimab.

The antibody cocktail is developed using Regeneron’s VelocImmune and VelociSuite technologies.

WHO clinical care head Dr Janet Diaz said: “This is a major breakthrough in the care of Covid-19 patients. This is our first recommendation for a therapeutic for those patients with mild, moderate disease, because it reduces the need for hospitalisation if they are at high risk.”

REGEN-COV was previously granted US emergency use authorization (EUA) in November last year after being used to treat former President Donald Trump’s Covid-19 illness.

Last month, the therapy was also granted conditional marketing authorization (CMA) in the UK and is under review in Europe.

UNITAID, a WHO-hosted international health agency, is negotiating with Roche, which is manufacturing the drug, for lower prices and equitable distribution across all parts of the world.

Furthermore, WHO is in discussions with the company for donation and distribution of the Covid-19 antibody drug cocktail through UNICEF, after it sets an allocation criterion.

In a statement, the agency said: “WHO has launched a call to manufacturers who may wish to submit their products for pre-qualification, which would allow for a ramping-up of production and therefore greater availability of the treatment and expanded access.”

The agency further called for the sharing of technology to facilitate the production of biosimilars.

Recently, the US government signed an agreement with Regeneron to buy 1.4 million additional doses of REGEN-COV.