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Pharmaceutical company Roche India on Wednesday declared that the Central Drugs Standards Control Organization (CDSCO) has granted Emergency Use Authorization (EUA) in India for the Riche’s antibody cocktail or the treatment of Covid-19.
V Simpson Emmanuel, Managing Director, Roche Pharma, India stated, “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 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.”
The antibody cocktail comprising of Casirivimab and Imdevimab getting an approval was dependent on the data that has been registered for the EUA under the United States, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
The technique of Recombinant DNA technology is utilized for producing Casirivimab and Imdevimab, which are human immunoglobulin G-1 monoclonal antibodies.
Monoclonal antibodies are proteins curated in the laboratory which replicate the immune system’s ability to tackle the harmful pathogens like the viruses. Both of these are that type of monoclonal antibodies that are particularly directed against the spike protein of SARS-CoV-2, which causes Covid-19 and further structured to inhibit the attachment of the virus and subsequent entry into the human cells.
In a statement, the company said, “Thanks to its specific engineering of two neutralising 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 neutralisation potency against new emerging variants.”
The Emergency Use Authorization will facilitate Roche for importing to India the globally manufactured product batches and will then be marketed and then distributed throughout the country via strategic partnership with Cipla Limited.
Umang Vohra, MD and Global CEO, Cipla stated, “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.”
Roche’s antibody cocktail granted approval in India for Covid-19 treatment
