Roche India gets emergency use approval for antibody cocktail used in COVID-19 treatment
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Last Updated: May 05, 2021, 08:04 PM IST
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Synopsis
The antibody cocktail is to be administered for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease, the statement said.
PTI
Drug firm Roche India on Wednesday said it has received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for Roche s investigational antibody cocktail used in the treatment of COVID-19. The approval of antibody cocktail of Casirivimab and Imdevimab in India was based on the data filed for the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union, Roche India said in a statement.
May 05, 2021
Company to partner with Cipla for pan-India distribution Roche India on Wednesday received Emergency User Authorisation (EUA) from regulator - Central Drugs Standards Control Organisation (CDSCO) for antibody cocktail (Casirivimab and Imdevimab) to be used for treatment of mild to moderate Covid-19 in adults and kids aged 12 years or older in India.
The approval was based on the data filed for the EUA in the United States and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
The EUA will enable Roche to import the globally manufactured product batches to India. Company will market and distribute these products in India through its strategic partner Cipla Limited.
Roche receives Emergency Use Authorisation in India for its investigational Antibody Cocktail used in the treatment of Covid-19 equitybulls.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from equitybulls.com Daily Mail and Mail on Sunday newspapers.
This emergency use authorisation (EUA) will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited.
by Swarajya Staff - May 3, 2021 08:17 AM
Merck Pharma
Snapshot
Molnupiravir is currently undergoing a phase-3 trial for the treatment of non-hospitalised patients with confirmed Covid-19.
An experimental oral antiviral drug called molnupiravir, manufactured by the American pharmaceutical company, Merck, is expected to help stem the cases of coronavirus in India.
The company, which is also known as MSD outside the United States and Canada, announced earlier last week that it has entered into non-exclusive voluntary licensing agreements for the drug with five established Indian generics manufacturers.
Even though there are two Covid-19 vaccines in IndiaâCovaxin and Covishieldâ it is believed that molnupiravir would play a key role in fighting the massive health crisis in the country.