Cipla To Market Roche’s Drug Cocktail To Treat Covid-19 In India
Roche Holding AG has received restricted emergency use approval from the Indian drug regulator for a product used to treat Covid-19 infections.
This will enable Roche Pharma India to import the product—a cocktail of the antibodies casirivimab and imdevimab—in India, Cipla Ltd. said in an exchange filing, adding it will market and distribute it in the country.
Approval was granted based on data that have been filed for emergency use in the U.S., and the scientific opinion of the Committee for Medicinal Products for Human Use in the European Union, Cipla said.
The product will be used to treat mild to moderate Covid-19 in adults and paediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and are at high risk.
“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, was quoted as saying. The drug will be available through leading hospitals and Covid-19 treatment centres in India.
In March, Roche said a large phase III global trial in high-risk non-hospitalised Covid-19 patients met its primary endpoint, which showed casirivimab and imdevimab significantly reduced risk of hospitalisation or death by 70% compared to placebo. The antibody cocktail also significantly shortened the duration of symptoms by four days, Cipla said.
Last month Cadila Healthcare Ltd. received restricted emergency use approval from the Indian drug regulator for its pegylated interferon alpha-2b, or virafin, for treating moderate Covid-19 infection in adults.