Coronavirus company news summary – Regeneron’s antibody cocktail receives EUA from FDA – Pfizer and BioNTech submit EUA to the FDA for Covid-19 vaccine

23 November 2020 (Last Updated November 23rd, 2020 08:56)

23 November 2020

Regeneron Pharmaceuticals has announced that its antibody cocktail casirivimab and imdevimab, also known as REGN-COV2 or REGEN-COV2, has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA). The drugs can be used for treating adults suffering with mild to moderate Covid-19 symptoms and  children aged 12 years or over weighing 40kg or more who are at risk of developing severe symptoms.

Health Canada granted interim authorisation for the use of Eli Lily’s neutralising antibody bamlanivimab (LY-CoV555) for the treatment for adults and children aged 12 years and older who may be suffering from mild to moderate Covid-19 symptoms. The authorisation is based on data from the BLAZE-1 trial, a randomised, double-blind placebo-controlled Phase II study which showed reduced viral load and symptom as well as hospitalisation rates.

Pfizer and BioNTech announced that the companies will be submitting a request for emergency use authorisation (EUA) to the FDA for their mRNA vaccine candidate, BNT162b2 to fight against the SARS-CoV-2 virus. This will enable the provision of the vaccine among high-risk populations in the US by end of December 2020.

The Dow University of Health Sciences in Pakistan published positive results from the clinical trials of Covid-19 intravenous immunoglobulin (C-IVIG). The medical institute announced that C-IVIG showed 100% recovery rate among severe patients, and over 60% recovery in critical patients, and with more than 50% recovered and discharged within five days.