PremiumNEW DLEHI : Roche India today announced that the Central Drugs Standards Control Organisation (CDSCO) has given an emergency authorisation for the antibody cocktail developed by US-based Regeneron for treatment of covid-19.
An antibody cocktail is mixture of two or more unique biological drugs that act like human antibodies in the immune system, and thereby fight the disease.
Premium Premium 
Premium Premium 
Premium Premium 
Premium Premium The authorisation in India will allow Roche to import the manufactured batches of the antibody cocktail of casirivimab and imdevimab, which will be marketed and distributed in India through a strategic partnership with Cipla Ltd. Cipla is already the exclusive importer and distributor of tocilizumab, for which Roche has the patent.
Roche India said that it will do everything to ensure an equitable distribution across the globe, but initial local demand may far exceed the supplies the company will be able to provide in India.
“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," V. Simpson Emmanuel, managing director of Roche Pharma India, said in a statement.
The antibody cocktail for which Roche got the authorisation had become famous for its use as an experimental therapy prescribed to former US president Donald Trump when he had covid-19 in October.
A month later, the drug received the US Food and Drug Administration’s emergency use authorisation for treatment of covid-19 following clinical trials which showed there was a reduction in covid-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Last month, Roche announced results from its phase 3 global trial of 4,567 high-risk non-hospitalised covid-19 patients, which showed that antibody cocktail reduced the risk of hospitalisation or death by 70% compared to placebo, and also shortened the duration of symptoms by four days.
CDSCO’s authorisation was based on the EUA in the US as well as the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
Never miss a story! Stay connected and informed with Mint. Download our App Now!!
