India approves Roche antibody cocktail to treat Covid-19
The antibody cocktail comprising Casirivimab and Imdevimab has been permitted by the Central Drugs Standards Control Organisation for the treatment of mild to moderate Covid-19 in high-risk patients.
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FollowIndia has given Emergency Use Authorisation for Roche's investigational antibody cocktail to be used in the treatment of Covid-19.
The antibody cocktail comprising Casirivimab and Imdevimab has been permitted by the Central Drugs Standards Control Organisation for the treatment of mild to moderate Covid-19 in high-risk patients.
This approval was based on the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union and the data submitted by Roche for similar approvals in the United States.
Casirivimab and Imdevimab are 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 2-8 degree celsius.
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 above) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease.
In a statement, Roche Pharma India Managing Director V Simpson Emmanuel said his firm is committed to minimise hospitalisations and ease pressure on healthcare systems.
"This is where neutralising antibody cocktails like casirivimab and imdevimab can play a role in the fight against COVID-19 and in the treatment of high-risk patients before their condition worsens. We are thankful to the CDSCO for granting a EUA for casirivimab and imdevimab. This outpatient treatment for COVID-19 will be complementary to the ongoing vaccination drive and support fight against Coronavirus in India," he said.
Roche claims that the human immunoglobulin G-1 (IgG1) monoclonal antibodies are lab-made proteins that mimic the immune system's ability to fight off harmful pathogens.
Casirivimab and Imdevimab are specifically directed against the spike protein of Covid-19, designed to block the virus' attachment and entry into human cells.
Umang Vohra, managing director and Global CEO of Cipla, which will market and distribute Roche's drug in India, said: "We are deeply committed to exploring all possible treatment options and being at the forefront in our fight against COVID-19. This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of Caring for Life."
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