Two US government departments – Health and Human Services (HHS) and Defense (DoD) – will purchase an additional 1.4 million doses of Regeneron’s REGEN-COV (casirivimab and imdevimab) amid surging demand for the antibody cocktail.
REGEN-COV has been authorised for emergency use in the US for both treatment and prevention of COVID in patients deemed at high risk of progressing to severe disease.
“More than a year and a half into this pandemic, too many people are still being hospitalised and dying due to COVID-19,” said Regeneron president and CEO, Leonard S Schleifer. “While vaccination remains the first line of defence to decrease the burden of COVID-19, REGEN-COV is a key tool that reduces the risk of hospitalisation or death by 70% in high-risk individuals when given early in the course of the infection.”
Regeneron will start to ship the extra doses immediately with the vast majority will be delivered in Q4.
REGEN-COV has not been approved by the Food and Drug Administration but was made available in November 2020 under emergency use approval for the treatment of COVID-19. The cocktail is not suitable for patients that already have severe COVID-19 but can be given to adults and children 12 or over with mild to moderate disease who are at high risk for progression to severe COVID-19, including hospitalisation or death.
In August, the emergency use was extended to cover post-exposure prophylaxis in adult and children 12 or over of COVID-19 who are at high risk for progression to severe COVID-19, including hospitalisation or death, and who have been in close contact with someone with the disease.
Under the new deal, the US government will pay $2,100 for each 1,200 mg dose of REGEN-COV, although patients receive the antibody combo free of charge.
Regeneron has also reported positive results from its phase 3 trials covering “the spectrum of COVID-19 infection, from prevention to hospitalisation”. This includes prevention of symptomatic infection in asymptomatic household contacts, treatment of non-hospitalised patients already infected with SARS-CoV-2, and treatment of certain patients hospitalised due to COVID-19 infection, including the UK RECOVERY trial.
Regeneron is collaborating with Roche to increase global supply of REGEN-COV, with Roche primarily responsible for development and distribution outside the US, although the Basel-based company will manufacture approximately one third of the newly ordered US doses.