Mumbai: The Central Drugs Standards Control Organisation (CDSCO) on Wednesday gave Roche India emergency use authorisation (EUA) for its antibody cocktail jab of Casirivimab and Imdevimab.
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 antibody cocktail jab can be administered for the treatment of mild to moderate coronavirus disease in adults and children aged 12 years or older and weighing at least 40 kg, and those who are at high risk of developing severe Covid-19 disease, the company said in a statement.
The combination therapy is approved at a combined dose of 1,200 mg (600 mg of each drug) administered by intravenous infusion or subcutaneous route. It has to be stored at 2-8 degrees Celsius.
The drugs have been made of two neutralising antibodies which bind to different parts of the virus spike. Thus, the Casirivimab and Imdevimab cocktail remains efficacious against widest spread variants and reduces the risk of losing its neutralisation potency against new emerging variants.
“With the increasing number of Covid-19 infections in India, Roche is committed to doing everything we can 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 treatment of high-risk patients before their condition worsens,” said V. Simpson Emmanuel, Managing Director, Roche Pharma India, in the statement.
“We are thankful to the CDSCO for granting an EUA for Casirivimab and Imdevimab. This outpatient treatment for Covid-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India,” Emmanuel added.
In November 2020, Casirivimab and Imdevimab antibody cocktail became the first combination therapy to receive emergency use authorisation by the US Food and Drug Administration. In March, Roche announced results of its large phase 3 global clinical trials, which showed that Casirivimab and Imdevimab can significantly reduce the risk of hospitalisation or death by 70 per cent compared to the placebo. Casirivimab and Imdevimab cocktail was also found to shorten the duration of symptoms by four days.
The approval will enable Roche to import the globally manufactured product batches to India. The drugs will be marketed and distributed in the country through its partnership with Cipla, while globally, the company has partnered with Regeneron Pharmaceuticals. The drug will be available through leading hospitals and Covid treatment centres.