USA – The World Health Organization (WHO) has added the Regeneron antibody drug cocktail (casirivimab and imdevimab) to its list of COVID-19 treatments, urging the manufacturer to lower its price and ensure equal access to the lifesaving treatment worldwide.
WHO added that Regeneron, the patent holder should also share technology to allow for the manufacturing of biosimilar versions of the monoclonal antibody therapy.
The guidelines published in the British Medical Journal (BMJ), strongly recommend that patients at high risk of hospitalization or with severe disease should be given a combination of two antibody treatments.
The first group consists of patients with non-severe COVID-19 who are at high risk of hospitalization, and the second group consists of patients with severe or critical COVID-19 who are seronegative, which means they have not mounted their own antibody response to COVID-19.
The first recommendation is based on new evidence from three trials that have not yet been peer reviewed, but show that casirivimab and imdevimab likely reduce the risk of hospitalization and the duration of symptoms in patients at highest risk of severe disease, such as those who are unvaccinated, elderly, or immunocompromised.
The second recommendation is based on data from another trial, which indicates that the two antibodies may reduce deaths and the need for mechanical ventilation in seronegative patients. This study found that Casirivimab and imdevimab treatment resulted in 49 fewer deaths per 1,000 severely ill patients and 87 fewer deaths in critically ill patients.
In November of last year, the antibody therapy received emergency use authorization in the United States after it was used to treat former President Donald Trump when he was admitted to the hospital with COVID-19. It has also been approved in the United Kingdom, and is currently being reviewed in Europe.
Casirivimab and imdevimab are monoclonal antibodies that, when combined, bind to the SARS-CoV-2 spike protein, preventing the virus from infecting cells.
The cocktail of Casirivimab and imdevimab, sold under the trademark name REGEN-COV, is administered intravenously for treatment; though it can be administered subcutaneously as an alternative route when intravenous infusion is not feasible and would cause treatment to be delayed.
It is the first COVID-19 drug that the WHO has recommended for use in non-severe high-risk patients to reduce the disease’s progression.