India has given an emergency use authorisation to a cocktail of drugs that will be used for the treatment of Covid-19 patients with mild to moderate symptoms.
Roche Pharma has partnered with Cipla Ltd. for pan-India production and distribution of the antibody cocktail of casirivimab and imdevimab, Cipla said in a stock exchange filing.
The approval has been granted on the basis of data that was filed for emergency use in the U.S. and scientific opinion from the European Union's Committee for Medicinal Products for Human Use, the release said.
The antibody cocktail is to be administered for treatment of mild-to-moderate Covid-19 patients that are at a high risk of developing severe disease. In March, Roche had announced that its phase III global trial of the treatment with 4,567 high-risk non-hospitalised patients had met a primary endpoint.
Cipla’s press release said that the antibody cocktail helped reduce the risk of hospitalisation or death by 70% compared to placebo. The two drugs also helped shorten the duration of symptoms by four days.
“We are thankful to the CDSCO for granting an EUA for casirivimab and imdevimab,” Simpson Emmanuel, Managing Director of Roche Pharma India said in a media release. “This outpatient treatment for Covid-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India.”