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FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

Regeneron HQ

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for priority review of REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalised patients and as prophylaxis in certain individuals.

The FDA has set a target action date of 13 April 2022 and plans to hold an advisory committee meeting to discuss the application before that date.

The BLA is supported by two positive phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalised patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts).

A second BLA submission focusing on the treatment of patients hospitalised due to COVID-19 is expected to be submitted later this year.

In Europe, the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application for review of the same antibody cocktail, known as Ronapreve in the EU, for use in certain people either as a treatment in infected non-hospitalised patients or as prophylaxis.

Earlier this year in May, detailed results from a phase 3 trial found that REGEN-COV significantly reduced the risk of hospitalisation or death by 70%, and also shortened symptom duration and reduced viral load in non-hospitalised patients with COVID-19.

The phase 3 trial evaluated REGEN-COV (casirivimab with imdevimab) in 4,567 high-risk outpatients with COVID-19.

All participants in this trial had at least one risk factor for developing severe COVID-19, including chronic lung disease, obesity, cardiovascular disease or were at least 50 years of age.

In June, the UK-based RECOVERY trial showed REGEN-COV improved survival in hospitalised COVID-19 patients who lack an immune response to the SARS-CoV-2 virus.

In the US, REGEN-COV has not been approved by the FDA, but is currently authorised for emergency use to treat patients with mild-to-moderate COVID-19 who are at high-risk of severe disease or hospitalisation.

Article by
Iona Everson

15th October 2021

From: Regulatory

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