The World Health Organization (WHO) has recommended a new combination of two antibody treatments for management of two categories of Covid-19 patients.
The antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in other countries, has already received emergency or temporary pandemic use authorizations to treat Covid-19 in more than 20 countries, including in the U.S., European Union, India, Switzerland and Canada.
The treatment is also known as the Regeneron antibody drug cocktail as the U.S. biotechnology company Regeneron Pharmaceuticals, Inc. (REGN) holds the patent to produce the antibody treatment.
The drug was successfully administered to former President Donald Trump when he tested positive for the disease last year.
The addition of another therapeutic to the world’s arsenal against the pandemic was approved by WHO Guideline Development Group (GDG) panel of international experts Friday.
The panel recommended a treatment combining two antibodies – Casirivimab and Imdevimab – for patients with non-severe Covid-19, who are at highest risk of hospitalization and those with severe or critical Covid-19 who are seronegative. Patients with seronegative status means those who have not developed natural antibodies against Covid-19 determined through accurate rapid tests.
A mixture of Casirivimab and imdevimab monoclonal antibodies act like human antibodies in the immune system and help neutralize coronavirus‘s ability to infect cells.
WHO’s Conditional recommendation for patients with non-severe Covid-19 reads: Whereas casirivimab and imdevimab achieves a substantial reduction in the relative risk of hospitalization, the absolute benefit will be trivial or unimportant in absolute terms for all but those at highest risk for which the intervention should be reserved. The panel identified a risk beyond 10% of being hospitalized for Covid-19 to represent a threshold at which most people would want to be treated with casirivimab and imdevimab. Typical characteristics of people at highest risk include lack of vaccination, older people, or those with immunodeficiencies and/or chronic diseases such as diabetes.
Conditional recommendation for patients with severe or critical Covid-19 reads: With benefits of casirivimab and imdevimab observed only in patients with seronegative status, clinicians will need to identify these patients by credible tests available at the point of care to appropriately apply this recommendation.
Treatment with casirivimab and imdevimab is in addition to the current standard of care, which includes corticosteroids and IL-6 receptor blockers.
The recommendations were accompanied by a call by WHO to producing companies and governments to address the high price and limited production of the Regeneron antibody combination and ensure safe and appropriate handling of the medicine.
The antibody cocktail was developed by Regeneron and Swiss drug maker Roche Pharmaceutical.
WHO said in a statement that given the high cost and low availability of the combination therapy, UNITAID is negotiating with Roche, which is currently manufacturing the drug for lower prices and equitable distribution across all regions, especially in low- and middle-income countries. WHO is also in discussions with the company for a donation and distribution of the drug through UNICEF, following an allocation criteria set by WHO.
In parallel, 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.
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