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Regeneron’s COVID-19 antibody cocktail scores FDA emergency approval

Drug approved to treat high-risk patients with mild to moderate COVID-19

A COVID-19 antibody cocktail developed by Regeneron has been given an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

REGN-COV2, which combines monoclonal antibodies casirivimab and imdevimab, has been granted an EUA for the treatment of mild to moderate COVID-19 in adults and paediatric patients at least 12 years of age who weigh at least 40kg and are at high risk of progressing to severe COVID-19 and/or hospitalisation.

Under the EUA, the recommended dose for REGN-COV2 is 1,200mg of casirivimab and 1,200mg of imdevimab administered as a single intravenous infusion.

Regeneron has already 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.

Regeneron now expects to have treatment doses ready for approximately 80,000 patients by the end of November, as well as doses for 200,000 patients by the first week of January next year and 300,000 patients in total by the end of January 2021.

“The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximise production of our antibody cocktail,” said Leonard Schleifer, president and chief executive officer of Regeneron.

“Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need,” he added.

The EUA is based on data from the first 799 adults in an ongoing trial of non-hospitalised COVID-19 outpatients.

In this study, REGN-COV2 met the primary endpoint in average daily change in viral load until day seven in patients with high viral load.

On a key clinical endpoint, REGN-COV2 treatment reduced COVID-19-related medical visits by 57% until day 29.

Treatment with REGN-COV2 also reduced COVID-19-related medical visits by 72% in patients with one or more risk factors.

The antibody cocktail will continue to be evaluated in phase 2/3 clinical trials for the treatment of COVID-19 in certain hospitalised and non-hospitalised patients, as well as in a UK-based phase 3 trial of hospitalised patients.

Another phase 3 trial is also studying REGN-COV2 for the prevention of COVID-19 in household contacts of infected individuals.

Last week, Eli Lilly and Incyte’s repurposed arthritis treatment baricitinib also scored an EUA in combination with Gilead’s remdesivir for the treatment of hospitalised COVID-19 patients.

Lilly’s monoclonal antibody treatment bamlanivimab was also granted an EUA from the FDA for the treatment of COVID-19 earlier this month.

The EUA covers bamlanivimab 700mg for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients. It is not authorised, however, for patients who are hospitalised as a result of COVID-19 or who require oxygen therapy due to COVID-19.

Article by
Lucy Parsons

23rd November 2020

From: Regulatory

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