Roche India on Wednesday said it has received emergency use authorisation (EUA) of the Central Drugs Standards Control Organisation for antibody cocktail (Casirivimab and Imdevimab) that is indicated for treatment of mild to moderate COVID-19.
The EUA will enable Roche to import the globally manufactured product batches to India where it has a partnership with Cipla to market as well as distribute the same. The approval was based on the data that have been filed for the EUA in the U.S. and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
A release from Roche, on the EUA, said the antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and at high risk of developing severe COVID-19 disease.
“Neutralising antibody cocktails like casirivimab and imdevimab can play a role in the fight against COVID-19. This outpatient treatment will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India,” said V. Simpson Emmanuel, Managing Director of Roche Pharma India.
The drug will be available through leading hospitals and Covid treatment centres. Casirivimab and Imdevimab is approved at a combined dose of 1200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route. It has to be stored at 2°C to 8°C. Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology.
The production process for this biologic medicine is very complex and Roche was selected by Regeneron to expand worldwide production capacity, the release said.
