US could purchase over 1.5 million doses of Regeneron’s COVID-19 antibody cocktail
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.
The US government has agreed to purchase up to 1.25 million extra finished doses of Regeneron’s casirivimab and imdevimab antibody cocktail by 30 June 2021. The additional doses are for use in non-hospitalised COVID-19 patients and, according to the government, will be provided at no cost to patients, though healthcare facilities may charge fees related to administration.
According to Regeneron, with the new supply deal, the total potential purchase by the US is over 1.5 million doses, as the company is already supplying the US with enough casirivimab and imdevimab to treat approximately 300,000 people.
“We are doing all we can to lessen the impact of the ongoing COVID-19 pandemic, and we remain committed to collaborating with Regeneron to increase supply of their antibody cocktail,” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “Casirivimab and imdevimab will be critically important to help address the pandemic if approved, and we will continue to work with regulators and governments across the globe to bring the medicine to as many people as possible.”
The efficacy and safety of casirivimab and imdevimab are currently being evaluated in clinical trials for the treatment of COVID-19 in certain hospitalised and non-hospitalised patients. Such trials include the open-label RECOVERY trial of hospitalised patients in the UK and a trial for the prevention of COVID-19 in household contacts of infected individuals. To date, nearly 15,000 people have participated in clinical trials involving the antibody cocktail.
Roche is collaborating with Regeneron to increase the global supply of casirivimab and imdevimab, their aim is to have more than two million treatment doses available annually. Regeneron is responsible for the development and distribution of the treatment in the US and Roche is primarily responsible for the development and distribution outside the US.
About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies that was designed by Regeneron scientists to prevent SARS-CoV-2, the virus that causes COVID-19, from binding to the human receptor that allows it to infect cells. The two antibodies are believed to bind non-competitively to the critical receptor binding domain of the virus’s Spike protein.
While casirivimab and imdevimab have not been US Food and Drug Administration (FDA) approved, they have been given Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation.