"This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited," it added.
Drug firm Roche India on Wednesday said it has received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for Roche’s investigational antibody cocktail used in the treatment of COVID-19.
The approval of antibody cocktail of Casirivimab and Imdevimab in India was based on the data filed for the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union, Roche India said in a statement.
“This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited,” it added.
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 older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease, the statement said.
It could significantly help these high-risk patients before their condition worsens, it added.
“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,”?Roche Pharma India MD V Simpson Emmanuel said.
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, it added.
Cipla MD?and Global CEO Umang Vohra said, “This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of ‘Caring for Life'”.
Cipla will market and distribute the product in India by leveraging its? distribution strengths across the country.
The drug will be available through leading hospitals and COVID treatment centres, Roche India said.