New Update
Roche India announced on May 5 that it has received the Emergency Use Authorisation (EUA) for the antibody cocktail Casirivimab and Imdevimab for treatment of COVID-19 in India.
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This was approved by the Central Drugs Standards Control Organisation (CDSCO). "The production process for this biologic medicine is very complex and Roche, as one of the largest biologics manufacturers in the world, was selected by its partner Regeneron to expand worldwide production capacity," Roche said.
The approval for the antibody cocktail has been given on the basis of the data for the EUA in the United States. The scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union has also been taken.
Here's what we know about the COVID-19 antibody cocktail:
- Casirivimab and imdevimab are monoclonal antibodies that have been specifically made to attack the spike protein of SARS-CoV-2. It will help in blocking the virus' attachment to human cells.
- The antibody cocktail will be marketed and distributed by pharmaceutical giant Cipla in India. It will be made available in most of the leading hospitals, and COVID-19 centres.
- The antibody cocktail - Casirivimab and Imdevimab is supposed to be used for treating adults and children (12 years of age or older, at least weighing 40 kg) with mild to moderate COVID-19 infection. The cocktail can help these patients who are at a higher risk of developing a severe infection.
- About a month ago, Roche announced that the cocktail was pivotal in reducing hospitalisation, and death by 70 per cent during the phase III global trial. This was carried out on high-risk non-hospitalised COVID-19 patients.
- The antibody cocktail can be administered via intravenous infusion or subcutaneous route. A combined dosage of 1200 mg (600 mg of each drug) has been approved. Besides this, the cocktail will have to be stored at 2 °C to 8 °C.