EUA FOR CASIRIVIMAB & IMDEVIMAB

Subject: Science & tech

Context: India approves Roche/ Regeneron antibody cocktail to treat COVID-19.

Concept:

The EUA will now enable Roche to import globally manufactured product batches to India that will be marketed as well as distributed in India through a strategic partnership with Cipla Ltd.
The antibody cocktail is to be administered to adults and paediatric patients (12 years or older, weighing at least 40 kg), who are confirmed to be infected with the novel coronavirus.
The treatment will be complementary to the ongoing vaccination drive and support the fight against the pandemic in India.
The approval is based on data filed for the EUA in the US and scientific opinion of Committee for Medicinal Products for Human Use (CHMP) in European Union.

Casirivimab and Imdevimab

Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology.
The antibody cocktail (Casirivimab and Imdevimab) is seen useful for high-risk patients before their condition worsens.
Casirivimaband imdevimab significantly shortened the duration of symptoms by four days during the clinical trials.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.
Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2.
They are designed to block the virus’ attachment and entry into human cells.
It should be refrigerated unopened vials at 2°C to 8°C (36°F to 46°F) in the individual original carton to protect from light.