Pharma giant Roche India has received the Emergency Use Authorisation (EUA) for a COVID-19 antibody-drug cocktail Casirivimab and Imdevimab in the country for the treatment of coronavirus patients. The drug cocktail is developed by Roche and Regeneron.
The approval was granted by the Central Drugs Standards Control Organisation (CDSCO) basis data filed with the US regulators as well as the scientific opinion of a European regulatory panel. This will further expand India's arsenal of drugs to fight a massive second wave of COVID-19.
The antibody treatment was administered to former US President Donald Trump after he was diagnosed with COVID-19. Roche will import the antibody cocktail, which will be marketed and distributed in India via a strategic partnership with Cipla Ltd.
Cipla is also the exclusive importer and distributor of Roche India's patented antibody Tocilizumab. The therapy is a cocktail of two antibodies, Casirivimab and Imdevimab, which are synthetically manufactured copies of antibodies that the body produces after an infection.
It has been shown to reduce hospitalisations in COVID-19 patients who are at a high risk of developing severe illness. The drug already has similar authorisation in the US and is used in Europe's non-hospitalised patients.
Cipla said the drug is meant for people with mild-to-moderate infection, who are at the high risk of developing severe disease. The company did not provide a price or launch date.
In the last 10 days, more than 33,000 Indians have died of COVID-19, with the country facing a severe shortage of COVID-19 medicines, including Gilead's Remdesivir and Roche's Tocilizumab.
Both the government and local manufacturers have said they are working to ramp up production. Smaller Indian drugmaker Natco Pharma said on Monday it received emergency use authorisation for Baricitinib, originally developed by Eli Lilly, to be used with Remdesivir to treat COVID-19.
India's official tally of coronavirus infections has crossed 20 million and is second only to the United States. Deaths have reached 226,188, but experts say the real tally could be several times higher.