The Central Drugs Standards Control Organisation (CDSCO) has granted emergency use authorization (EUA) approval for pharmaceutical company Roche’s antibody cocktail for COVID-19 treatment in India.
“With the increasing number of COVID-19 infections in India, Roche is committed to doing everything we can to minimize hospitalizations and ease pressure on healthcare systems. This is where neutralizing 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. This outpatient treatment for COVID-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India,” said Roche Pharma India managing director V Simpson Emmanuel.
The approval for Casirivimab and Imdevimab was based on data filed in the US and scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
What are Casirivimab and Imdevimab?
Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by DNA technology.
“Thanks to its specific engineering of two neutralizing antibodies which bind to different parts of the virus spike, the casirivimab and imdevimab cocktail remains efficacious against widest spread variants and reduces the risk of losing its neutralization potency against new emerging variants,” Roche said in a statement.
Who can be treated?
Casirivimab-imdevimab can be used to treat mild to moderate COVID-19 cases in adults and children aged 12 or more. Those who are infected with SARS-COV2 and weigh at least 40 kg, and are at high risk of the disease turning severe, can be administered the antibody cocktail.
Roche announced on March 23, 2021 that a large phase III global trial showed that Casirivimab and Imdevimab significantly reduced the risk of hospitalization or death by 70% compared to placebo. The cocktail antibodies also shortened duration of symptoms by four days.
Dosage
A combined dose of 1200 mg (600 mg each of Casirivimab and Imdevimab) has been approved to be administered by intravenous infusion or subcutaneous route. It has to be stored at 2°C to 8°C.
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