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All About Roche s COVID Antibody Cocktail That India Approved As Treatment For Mild Cases
A Switzerland based drug maker, Roche has received approval from India s Central Drugs Standards Control Organisation (CDSCO) for COVID-19 emergency use .
Image: PTI
Widening the arsenal of drugs to combat COVID-19, a Switzerland-based drug maker, Roche has received approval from India s Central Drugs Standards Control Organisation (CDSCO) for use in emergency situations for treatment of COVID-19. The said experimental antibody cocktail was consumed by former US President Donald Trump when he contracted COVID-19 infection last year during his tenure at the White House.
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.
India approves Roche s antibody cocktail to treat COVID-19; Cipla to distribute the drug
The approval was granted by the Central Drugs Standards Control Organisation (CDSO) basis data filed with the US regulators as well as the scientific opinion of a European regulatory panel
BusinessToday.In | May 6, 2021 | Updated 09:53 IST
A logo of Swiss pharmaceutical company Roche in Rotkreuz, Switzerland, April 12, 2012. (Photo: Reuters)
Pharma giant Roche India has received the Emergency Use Authorisation (EUA) for a COVID-19 antibody-drug cocktail Casirivimab and Imdevimab in the country for the treatment of coronavirus patients. The drug cocktail is developed by Roche and Regeneron.
The approval was granted by the Central Drugs Standards Control Organisation (CDSCO) basis data filed with the US regulators as well as the scientific opinion of a European regulatory panel. This will further expand India s arsenal of drugs to fight a massive second wave of COVID-19.
The Casirivimab-Imdevimab injection is a cocktail of two monoclonal antibodies and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19. The monoclonal antibodies are produced by recombinant DNA technology.The
Updated:
May 05, 2021 20:18 IST
This 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
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The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland. | Photo Credit:
Reuters
This 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
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.
F. Hoffmann-La Roche Ltd: Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
Placebo
Risk reduction
13
1.2
4 copies/mL)
14
0.4
Individuals without any COVID-19 symptoms who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days
. Based on the seronegative modified Full Analysis Set population, which includes all randomized subjects without evidence of current or prior SARS-CoV-2 infection (i.e., a negative RT-qPCR test and a negative antibody test) at randomization.
Adverse events (AEs) occurred in 20% (n=265 out of 1,311) of REGEN-COV participants and 29% (n=379 out of 1,306) of placebo participants, and serious AEs occurred in 1% (n=10) of REGEN-COV participants and 1% (n=15) of placebo participants. There were 0 REGEN-COV participants and 4 placebo participants who were either hospitali