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Regeneron seeks US emergency use authorisation for COVID-19 antibody cocktail

If approved, the US government will make initial doses available at no cost

Regeneron has applied for an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 antibody cocktail, REGN-COV2.

The drug has been the focus of attention since reports confirmed that it had been given to US president Donald Trump after he tested positive for the novel coronavirus last week.

If an EUA is granted the US government has committed to making the initial doses of REGN-COV2 available at no cost to American citizens and would be responsible for their distribution.

Regeneron previously signed a manufacturing and supply agreement with the US Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defence for REGN-COV2.

As part of that agreement, Regeneron was awarded a $450m contract by the government bodies to manufacture and supply the antibody cocktail.

The company added in a statement that currently, there are REGN-COV2 doses available for approximately 50,000 patients, with Regeneron expecting to have doses available for another 300,000 patients in total within the next few months.

Last month, Regeneron released data from the first descriptive analysis of REGN-COV2, in which the treatment demonstrated the ability to reduce viral load and speed up recovery time in non-hospitalised COVID-19 patients.

The promising results came from a large programme investigating REGN-COV2 in non-hospitalised COVID-19. Regeneron is also investigating the cocktail as a treatment for hospitalised COVID-19 patients and for the prevention of infection on people who have been exposed to the virus.

The antibody treatment also recently advanced into a phase 3 trial in the UK, coordinated by researchers from Oxford University. The study, dubbed RECOVERY, is investigating Regeneron’s investigational treatment in patients hospitalised with COVID-19, and is set to compare the effects of adding the cocktail to the usual standard-of-care versus standard-of-care treatment alone.

Another phase 3 prevention trial is set to be conducted at around 100 sites across the US, and will enrol approximately 2,000 patients with the aim of assessing SARS-CoV-2 infection status.

In August, Regeneron also signed a deal with Roche to bolster manufacturing and global development capabilities for the antibody cocktail. Under the terms of this agreement, Regeneron will distribute and record sales of the antibody cocktail in the US, while Roche will be responsible for distribution outside of the US.

The collaboration is expected to increase the supply of REGN-COV2 by at least three and a half times its current capacity, according to Roche. As part of the deal, Roche and Regeneron are jointly funding and executing the ongoing phase 3 prevention trial, as well as further phase 1 safety studies.

Article by
Lucy Parsons

12th October 2020

From: Regulatory



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