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Regulatory approval for Roche's antibody cocktail in India

Regulatory approval for Roches antibody cocktail in India

New Delhi: The antibody cocktail, used by former US President Donald Trump when he contracted Covid and developed by Roche, the Swiss pharmaceutical giant, was granted approval by the Central Drugs Standards Control Organisation (CDSCO) for use in emergency stages of Covid treatment.

What is the Antibody Cocktail?

The cocktail combines two antibodies, the Casirivimab and Imdevimab, two monoclonal antibodies that function as the immune system to protect from dangerous pathogens.

These hinder the access of viruses to human cells. Casirivimab and Imdevimab particularly act against the spike protein of SARS-CoV-2.

Who could it be prescribed to?

This antibody cocktail is used to treat people with a high risk of falling ill, including elders and children(12 and above). The approval is for the combined dose of 1200 mg(600 mg from each dose).

This antibody must be kept in an atmosphere between 2 degrees Celsius and 8 degrees Celsius and can also be prescribed for patients above the age of 60 with a high risk of falling ill and patients with heart or lung-related issues.

How effective is it?

Roche conducted the fourth phase test of antibody cocktail in 4567 patients with a high risk of falling ill and not admitted to the hospital. They found that the rate of fatality and admittance in the hospital could be reduced by 70%.

How much does it cost?

Roche imports the medicine in association with Cipla Limited. The cost and other information regarding the cocktail will be announced after discussing with Cipla, said V Simpson Emmanuel, the MD of Roche Pharma India.

Where else is it approved?

European Union and the US also approved the antibody cocktail.

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TAGS:Antibody cocktail regulatory approval Covid Updates 
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